Product Code: HQC FDA class 2 21 CFR 886.4670

Unit, Phacofragmentation

Ophthalmic

A Phacofragmentation Unit is an ophthalmic surgical device that uses ultrasonic vibration transmitted through a hollow needle to emulsify and aspirate the crystalline lens during phacoemulsification cataract surgery, allowing lens removal through a small incision. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQC and is regulated under 21 CFR 886.4670, within the Ophthalmic medical specialty. It is eligible for third-party review.

View on FDA

510(k)s

312

FEI Numbers

Registration Numbers

Unique Applicants

126

Years Active

Basic Information

Product Code: HQC
Device Class: FDA class 2
Regulation Number: 886.4670
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 312 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242801	MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)	Jun 11, 2025	Substantially Equivalent	Carl Zeiss Meditec Cataract Technology Inc.
K240169	Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)	Jul 26, 2024	Substantially Equivalent	Bausch and Lomb Incorporated
K233398	Faros Surgical System	Jun 27, 2024	Substantially Equivalent	Oertli Instrumente AG
K233876	UNITY VCS (8065000296); UNITY CS (8065000297)	Jun 21, 2024	Substantially Equivalent	Alcon Laboratories Inc.
K232084	Stellaris Elite vision enhancement system	Feb 26, 2024	Substantially Equivalent	Bausch and Lomb
K233902	Centurion Vision System (Active Sentry) (8065753057)	Jan 10, 2024	Substantially Equivalent	Alcon Laboratories, Inc.
K230858	QUATERA 700	Jul 31, 2023	Substantially Equivalent	Carl Zeiss Meditec AG
K214028	MICOR Lens Fragmentation System	Sep 09, 2022	Substantially Equivalent	Carl Zeiss Meditec Cataract Technology Inc.
K222236	miCOR System Lens Fragmentation System	Aug 24, 2022	Substantially Equivalent	Carl Zeiss Meditec Cataract Technology Inc.
K213467	EVA NEXUS Ophthalmic Surgical System	Jun 14, 2022	Substantially Equivalent	D.O.R.C. Dutch Ophthalmic Research Center (International)
K212241	QUATERA 700	Apr 19, 2022	Substantially Equivalent	Carl Zeiss Meditec AG
K203060	VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control	Mar 12, 2021	Substantially Equivalent	Johnson & Johnson Surgical Vision, Inc.
K200207	xPORT S Lens Fragmentation System	Oct 15, 2020	Substantially Equivalent	Carl Zeiss Meditec Cataract Technology Inc.
K200584	xPORT 304 (miCOR) System Lens Fragmentation System	Jul 31, 2020	Substantially Equivalent	Carl Zeiss Meditec Cataract Technology Inc
K193376	Visalis V500, Visalis S500	Jun 15, 2020	Substantially Equivalent	Carl Zeiss Meditec AG
K192418	Phacoemulsification Needle (Tip) and Irrigation Sleeve	May 27, 2020	Substantially Equivalent	Raico LLC
K191650	LEGION System	Nov 01, 2019	Substantially Equivalent	Alcon Research, LLC
K190875	EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)	Sep 25, 2019	Substantially Equivalent	D.O.R.C. Dutch Ophthalmic Research Center (International)
K191933	COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal	Aug 16, 2019	Substantially Equivalent	Johnson & Johnson Surgical Vision, Inc.
K191024	xPORT Lens Fragmentation System	Aug 13, 2019	Substantially Equivalent	Carl Zeiss Meditec Cataract Technology Inc.
K170052	Stellaris Elite vision enhancement system	Apr 19, 2017	Substantially Equivalent	Bausch + Lomb
K161794	CENTURION Vision System (Active SentryTM)	Apr 14, 2017	Substantially Equivalent	Alcon Research, Ltd.
K162342	Stellaris Elite Vision Enhancement System	Mar 24, 2017	Substantially Equivalent	Bausch + Lomb
K160236	Dual Pump Pack	Apr 27, 2016	Substantially Equivalent	Abbott Medical Optics Inc.
K151636	AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control	Oct 19, 2015	Substantially Equivalent	ABBOTT MEDICAL OPTICS INC
K151783	COMPACT INTUITIV Multiple-Use Pack	Sep 02, 2015	Substantially Equivalent	Abbott Medical Optics Inc.
K142877	EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)	Mar 13, 2015	Substantially Equivalent	DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
K133562	CATARHEX 3	Aug 12, 2014	Substantially Equivalent	OERTLI INSTRUMENTE AG
K133486	STELLARIS PC VISION ENHANCEMENT SYSTEM	Mar 12, 2014	Substantially Equivalent	BAUSCH & LOMB
K133115	COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK	Feb 27, 2014	Substantially Equivalent	ABBOTT MEDICAL OPTICS INC
K133242	STELLARIS VISION ENHANCEMENT SYSTEM	Feb 14, 2014	Substantially Equivalent	BAUSCH & LOMB
K121555	CENTURION VISION SYSTEM	Dec 21, 2012	Substantially Equivalent	ALCON LABORATORIES, INC.
K122829	LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS	Dec 03, 2012	Substantially Equivalent	LENSAR, INC.
K121721	LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)	Oct 15, 2012	Substantially Equivalent	ABBOTT MEDICAL OPTICS INC
K120732	LENSSX LASER SYSTEM	Sep 06, 2012	Substantially Equivalent	ALCON LENSX, INC.
K120912	INFINITI(R) VISION SYSTEM	Jun 15, 2012	Substantially Equivalent	ALCON MANUFACTURING, LTD.
K111446	SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM	Dec 21, 2011	Substantially Equivalent	ABBOTT MEDICAL OPTICS INC
K112425	INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE	Nov 21, 2011	Substantially Equivalent	ALCON MANUFACTURING, LTD.
K111882	LAMINAR FLOW PHACO TIPS	Nov 07, 2011	Substantially Equivalent	ABBOTT MEDICAL OPTICS INC
K111697	AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM	Sep 27, 2011	Substantially Equivalent	ABBOTT MEDICAL OPTICS INC
K103023	UNIT, PHACOFRAGMENTATION	Jun 01, 2011	Substantially Equivalent	ABBOTT MEDICAL OPTICS INC
K101285	CONSTELLATION VISION SYSTEM	Nov 12, 2010	Substantially Equivalent	ALCON MANUFACTURING, LTD.
K101325	STELLARIS PC VISION ENHANCEMENT SYSTEM	Aug 17, 2010	Substantially Equivalent	BAUSCH & LOMB, INC.
K093210	AQUALASE CAPSULE WASH TIP	Mar 04, 2010	Substantially Equivalent	ALCON MANUFACTURING, LTD.
K091915	FLUID ISOLATION DEVICE	Oct 27, 2009	Substantially Equivalent	LENSTEC, INC.
K091777	ALCON ULTRACHOPPER	Oct 20, 2009	Substantially Equivalent	ALCON RESEARCH, LTD.
K082845	INFINITI VISION SYSTEM WITH OZIL IP	Feb 12, 2009	Substantially Equivalent	ALCON RESEARCH, LTD.
K082473	BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM	Jan 05, 2009	Substantially Equivalent	BAUSCH & LOMB, INC.
K081877	ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS	Jan 05, 2009	Substantially Equivalent	DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
K080803	VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551	Sep 22, 2008	Substantially Equivalent	AMERICAN OPTISURGICAL, INC.
K082132	BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK	Aug 28, 2008	Substantially Equivalent	BAUSCH & LOMB, INC
K063583	ALCON VISION SYSTEM	May 09, 2008	Substantially Equivalent	ALCON
K073023	STERILS SINGLE-USE I/A HANDPIECES	Mar 12, 2008	Substantially Equivalent	BAUSCH & LOMB, INC.
K063331	BAUSCH & LOMB NGX MICROSURGICAL SYSTEM	Dec 19, 2006	Substantially Equivalent	BAUSCH & LOMB, INC.
K060366	THE AMO OPHTHALMIC SURGICAL SYSTEM	Apr 07, 2006	Substantially Equivalent	ADVANCED MEDICAL OPTICS, INC.
K051186	MICROPULSE PHACOEMULSIFICATION SYSTEM	Aug 18, 2005	Substantially Equivalent	TRILLIUM MEDICAL, INC.
K050648	SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK	Apr 05, 2005	Substantially Equivalent	ADVANCED MEDICAL OPTICS, INC.
K041998	PHACO CHOP NEEDLES	Aug 16, 2004	Substantially Equivalent	BAUSCH & LOMB, INC.
K033653	VENTURI PHACO PACK	Dec 17, 2003	Substantially Equivalent	BAUSCH & LOMB, INC.
K030957	PERFECT CAPSULE	Aug 20, 2003	Substantially Equivalent	MILVELLA PTY. LTD.
K031404	DIGNITY OPHTHALMIC SURGICAL SYSTEM	May 22, 2003	Substantially Equivalent	PHACOR INC., A SANTEN COMPANY
K022833	BENJAMIN ENVOY PHACO HANDPIECE	Sep 09, 2002	Substantially Equivalent	BENJAMIN BIOMEDICAL, INC.
K020527	HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030	Jul 09, 2002	Substantially Equivalent	AMERICAN OPTISURGICAL, INC.
K021566	INFINITI	Jul 02, 2002	Substantially Equivalent	ALCON LABORATORIES, INC.
K020734	SURGE-FREE ASPIRATION ADAPTER	May 16, 2002	Substantially Equivalent	STAAR SURGICAL CO.
K003638	MOJAVE CATARACT EXTRACTION SYSTEM	Feb 13, 2001	Substantially Equivalent	ALLERGAN, INC.
K003512	LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II	Feb 08, 2001	Substantially Equivalent	A.R.C. LASER AG
K002932	PHACOGARD	Jan 04, 2001	Substantially Equivalent	SYNTEC, INC.
K002031	PHACOFRAGMENTATION SYSTEM MEGATRON	Dec 27, 2000	Substantially Equivalent	ASCLEPION-MEDITEC AG
K002986	A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5	Nov 29, 2000	Substantially Equivalent	A.R.C. LASER AG
K002812	IRIS RETRACTING PHACOEMULSIFICATION SLEEVE	Nov 08, 2000	Substantially Equivalent	MICHAEL REYNARD, M.D.
K991852	OCUSYSTEM ART ADVANTAGE, MODEL 995	Jul 07, 1999	Substantially Equivalent	SURGICAL DESIGN CORP.
K984143	FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM	Feb 16, 1999	Substantially Equivalent	FIBRA SONICS, INC.
K981989	THE WAVE DIGITAL PHACO SYSTEM	Aug 25, 1998	Substantially Equivalent	CIRCUIT TREE
K981103	TURBOSONICS LIMITED REUSE ULTRASONIC TIP	Jun 23, 1998	Substantially Equivalent	ALCON LABORATORIES
K981109	QUITETIP	Jun 09, 1998	Substantially Equivalent	PARADIGM MEDICAL INDUSTRIES, INC.
K980480	SYNTEC VITMAN	May 04, 1998	Substantially Equivalent	SYNTEC, INC.
K980085	PHACO COMMANDER	Feb 24, 1998	Substantially Equivalent	SCIERAN TECHNOLOGIES, INC.
K974469	MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL	Feb 24, 1998	Substantially Equivalent	MENTOR CORP.
K974719	PHACOPAK	Jan 20, 1998	Substantially Equivalent	PARADIGM MEDICAL INDUSTRIES, INC.
K973749	FRAG COMMANDER	Dec 08, 1997	Substantially Equivalent	SCIERAN TECHNOLOGIES, INC.
K972063	WHITTINGHAM ULTRACLEAN PHACO HANDPIECE	Nov 25, 1997	Substantially Equivalent	WILLIAM F. WHITTINGHAM
K972253	P3 UNIVERSAL PHACO HANDPIECE	Jul 29, 1997	Substantially Equivalent	ODYSSEY TECHNOLOGIES, INC.
K972252	VISTA UNIVERSAL HANDPIECE	Jul 29, 1997	Substantially Equivalent	ODYSSEY TECHNOLOGIES, INC.
K971795	AUTOMATED CHAMBER MAINTENANCE MODULE	Jul 14, 1997	Substantially Equivalent	PARADIGM MEDICAL INDUSTRIES, INC.
K971750	WELCH ALLYN PHACO ILLUMINATOR	Jun 30, 1997	Substantially Equivalent	WELCH ALLYN, INC.
K971439	STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES	Jun 17, 1997	Substantially Equivalent	STORZ INSTRUMENT CO.
K971186	AMO DIPLOMAX/OPSYS CONSOLE	Jun 13, 1997	Substantially Equivalent	ALLERGAN, INC.
K971064	BAYERS BIMANUAL I/A HANDPIECES	Jun 09, 1997	Substantially Equivalent	VISION CARE DEVICES, INC.
K965127	DGH MODEL 9000	Mar 17, 1997	Substantially Equivalent	DGH TECHNOLOGY, INC.
K964018	PHACOILLUMINATOR - FIBEROPTIC SLEEVE	Feb 26, 1997	Substantially Equivalent	MICHAEL REYNARD, M.D.
K960287	HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM	Nov 05, 1996	Substantially Equivalent	NIDEK, INC.
K960811	PHACOSCOPE	Oct 02, 1996	Substantially Equivalent	SAINT JOHN'S PLAZA MEDICAL GROUP
K960024	STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH	Sep 20, 1996	Substantially Equivalent	STORZ INSTRUMENT CO.
K962402	AMO PRESTIGE DAY PACK (ALLERGAN, INC.)	Sep 19, 1996	Substantially Equivalent	ALLERGAN, INC.
K960003	STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION	Aug 29, 1996	Substantially Equivalent	STORZ INSTRUMENT CO.
K962131	STORZ D4600 AIR EXCHANGE LINE PACK	Aug 23, 1996	Substantially Equivalent	STORZ INSTRUMENT CO.
K961874	STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK	Aug 06, 1996	Substantially Equivalent	STORZ INSTRUMENT CO.
K961831	STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK	Aug 06, 1996	Substantially Equivalent	STORZ INSTRUMENT CO.
K961820	STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK	Jul 25, 1996	Substantially Equivalent	STORZ INSTRUMENT CO.
K962431	CTM DISPOSABLE PAK	Jul 23, 1996	Substantially Equivalent	CIRCUIT TREE MEDICAL, INC.
K962430	CTM REUSABLE PAK	Jul 23, 1996	Substantially Equivalent	CIRCUIT TREE MEDICAL, INC.
K961658	MEGATRON OPHTHALMIC SURGICAL SYSTEM	Jul 23, 1996	Substantially Equivalent	INTL. OPHTHALMIC INDUSTRIES CORP.
K961243	OCUSYSTEM ART ADVANTAGE	Jul 10, 1996	Substantially Equivalent	SURGICAL DESIGN CORP.
K961310	STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)	Jun 27, 1996	Substantially Equivalent	STORZ INSTRUMENT CO.
K960414	SYNERGIST POWER PACK	Apr 24, 1996	Substantially Equivalent	CHIRON VISION CORP.
K955901	STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX	Mar 28, 1996	Substantially Equivalent	STORZ INSTRUMENT CO.
K955789	ALCON SERIES 20000 LEGACY MACKOOL SYSTEM	Mar 21, 1996	Substantially Equivalent	ALCON LABORATORIES
K955245	MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM	Feb 12, 1996	Substantially Equivalent	MENTOR O & O, INC.
K954746	PHACO TIP	Jan 11, 1996	Substantially Equivalent	U.S. IOL, INC.
K953539	DM001 DISPOSABLE PACK	Dec 26, 1995	Substantially Equivalent	AMERICAN OPTISURGICAL, INC.
K953538	RM001 REUSABLE	Dec 26, 1995	Substantially Equivalent	AMERICAN OPTISURGICAL, INC.
K954340	STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE	Dec 14, 1995	Substantially Equivalent	STORZ
K954239	U.S. IOL PHACO HANDPIECE	Dec 08, 1995	Substantially Equivalent	U.S. IOL, INC.
K954238	SURGIN GENISIS HANDPIECE	Dec 08, 1995	Substantially Equivalent	SURGIN SURGICAL INSTRUMENTATION, INC.
K954237	CIRCUIT TREE PHACO HANDPIECE	Dec 08, 1995	Substantially Equivalent	CIRCUIT TREE
K954242	CIRCUIT TREE PHACOEMULSIFIER	Dec 01, 1995	Substantially Equivalent	CIRCUIT TREE
K954241	SURGIN GENISIS PHACOEMULSIFIER	Dec 01, 1995	Substantially Equivalent	SURGEON SURGICAL INSTRUMENTATION, INC.
K954240	EVOLUTION PHACOMULSIFIER	Dec 01, 1995	Substantially Equivalent	U.S. IOL, INC.
K953959	PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES	Nov 17, 1995	Substantially Equivalent	MICROSURGICAL TECHNOLOGY, INC.
K951463	STORZ I/A HANDPIECES	Oct 27, 1995	Substantially Equivalent	STORZ INSTRUMENT CO.
K953359	TRI-STAR UNIVERSAL I/A PHACO PAK	Oct 17, 1995	Substantially Equivalent	TRI-STAR OPHTHALMIC
K953447	PRECISIONIST THIRTY THOUSAND	Oct 13, 1995	Substantially Equivalent	PARADIGM MEDICAL INDUSTRIES, INC.
K944993	IOLAB.SITE CD PHACOEMULSIFICATION MODULE	Oct 12, 1995	Substantially Equivalent	CHIRON VISION CORP.
K944995	IOLAB/SITE PERISTALTIC MODULE	Oct 05, 1995	Substantially Equivalent	CHIRON VISION CORP.
K950881	PHACO TIP	Sep 06, 1995	Substantially Equivalent	AMERICAN OPTICAL CORP.
K952468	HI-LINE MEDICAL PHACOEMULSIFIER TIP	Aug 24, 1995	Substantially Equivalent	HI-LINE MEDICAL
K952331	AOI LC-40 PHACOEMULSIFIER	Aug 16, 1995	Substantially Equivalent	AMERICAN OPTISURGICAL, INC.
K952213	ALCON SERIES 20000 LEGACY PHACOEMULSIFIER	Aug 09, 1995	Substantially Equivalent	ALCON LABORATORIES
K953078	STORZ DP4101 BASIC I/A PACK	Aug 07, 1995	Substantially Equivalent	STORZ INSTRUMENT CO.
K951824	STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)	Jul 19, 1995	Substantially Equivalent	NIDEK, INC.
K950218	OMS SLIMLINE PHACO HANDPIECE	Jul 17, 1995	Substantially Equivalent	OPTICAL MICRO SYSTEMS, INC.
K946054	DIPLOMAX	Jul 11, 1995	Substantially Equivalent	OPTICAL MICRO SYSTEMS, INC.
K951462	AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM	Jun 15, 1995	Substantially Equivalent	ALLERGAN MEDICAL OPTICS
K952259	STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES	Jun 14, 1995	Substantially Equivalent	STORZ INSTRUMENT CO.
K950114	STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM	Jun 02, 1995	Substantially Equivalent	STORZ INSTRUMENT CO.
K950880	AOI UNIVERSAL ULTRASONIC HANDPIECE	May 26, 1995	Substantially Equivalent	AMERICAN OPTICAL CORP.
K950800	PRO-PAK FOR OMS DIPLOMATE	May 22, 1995	Substantially Equivalent	M. IMONTI AND ASSOCIATES INC.,
K950798	POSTERIOR CAPSULE SHIELD	May 22, 1995	Substantially Equivalent	OASIS MEDICAL, INC.
K950600	VACUUM SURGE SUPRESSER	May 10, 1995	Substantially Equivalent	SURGIN SURGICAL INSTRUMENTATION, INC.
K946227	STORZ PREMIERE(R) MICROSURGICAL SYSTEM	Mar 22, 1995	Substantially Equivalent	STORZ INSTRUMENT CO.
K944994	IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE	Mar 14, 1995	Substantially Equivalent	CHIRON VISION CORP.
K946176	STORZ PHACOEMULSIFICATION NEEDLES	Feb 14, 1995	Substantially Equivalent	STORZ INSTRUMENT CO.
K945583	OCUSYSTEM(ART)	Feb 13, 1995	Substantially Equivalent	ARENT FOX
K942945	CASSETTE SYSTEM FOR STORZ	Dec 05, 1994	Substantially Equivalent	SURGIN SURGICAL INSTRUMENTATION, INC.
K935926	STORZ PHACO AND FRAG HANDPIECES	Nov 28, 1994	Substantially Equivalent	STORZ INSTRUMENT CO.
K943672	PHACO NEEDLES AND TIPS	Oct 13, 1994	Substantially Equivalent	MICROSURGICAL TECHNOLOGY, INC.
K943379	PHACO TIPS FOR PHACO FRAGMENTATION MACHINES	Oct 11, 1994	Substantially Equivalent	OASIS MEDICAL, INC.
K940083	STANDARD PHACO TIP 15, 30, 45, 60	Sep 28, 1994	Substantially Equivalent	MEDICAL TECHNICAL PRODUCTS
K940088	MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE	Aug 04, 1994	Substantially Equivalent	MEDICAL TECHNICAL PRODUCTS
K943102	HIGH PERFORMANCE TIPS	Jul 28, 1994	Substantially Equivalent	SURGIN SURGICAL INSTRUMENTATION, INC.
K942518	CASSETTE SYSTEM FOR SITE	Jul 25, 1994	Substantially Equivalent	SURGIN SURGICAL INSTRUMENTATION, INC.
K942517	10-K CASSETTE	Jul 25, 1994	Substantially Equivalent	SURGIN SURGICAL INSTRUMENTATION, INC.
K942516	10-0 CASSETTE	Jul 25, 1994	Substantially Equivalent	SURGIN SURGICAL INSTRUMENTATION, INC.
K942515	PHACO KIT	Jul 25, 1994	Substantially Equivalent	SURGIN SURGICAL INSTRUMENTATION, INC.
K940084	MODEL 2000 OPHTHALMIC SURGICAL SYSTEM	Jun 17, 1994	Substantially Equivalent	MEDICAL TECHNICAL PRODUCTS
K923630	PHACO NEEDLES 1000-R & 1000-O NEEDLES	Apr 06, 1994	Substantially Equivalent	O.R. SPECIALTIES, INC.
K935223	OPHTHALMIC SURGICAL SYSTEM	Mar 14, 1994	Substantially Equivalent	OPTICAL MICRO SYSTEMS, INC.
K931358	AORP4000 REUSABLE PAK	Feb 22, 1994	Substantially Equivalent	AMERICAN OPTICAL CORP.
K931354	P4000 PHACOEMULSIFIER	Feb 22, 1994	Substantially Equivalent	AMERICAN OPTICAL CORP.
K925828	MODIFIED SITE TXR SYSTEMS	Feb 16, 1994	Substantially Equivalent	SITE MICROSURGICAL SYSTEMS, INC.
K933627	PHACOFRAGMENTOR TIP	Jan 25, 1994	Substantially Equivalent	M. IMONTI AND ASSOCIATES INC.,
K931357	AOD4000 DISPOSABLE PAK	Jan 25, 1994	Substantially Equivalent	AMERICAN OPTICAL CORP.
K933503	PRO-PHACO HANDPIECE	Jan 06, 1994	Substantially Equivalent	M. IMONTI AND ASSOCIATES INC.,
K926381	OCUSYSTEM IIE	Dec 06, 1993	Substantially Equivalent	SURGEON DESIGN
K931866	SITE'S CD II PHACOEMULSIFICATION HANDPIECE	Nov 12, 1993	Substantially Equivalent	SITE MICROSURGICAL SYSTEMS, INC.
K926512	STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE	Sep 09, 1993	Substantially Equivalent	STORZ
K925631	PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE	Jul 29, 1993	Substantially Equivalent	CHIRON INTRAOPTICS
K924260	NIDEK CV-12000	Mar 26, 1993	Substantially Equivalent	NIDEK, INC.
K923725	OPHTHALMIC PHARCO NEEDLE	Mar 18, 1993	Substantially Equivalent	SYNERGETICS, INC.
K925254	AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38	Jan 07, 1993	Substantially Equivalent	ALLERGAN MEDICAL OPTICS
K924235	AMO ELITE	Dec 23, 1992	Substantially Equivalent	ALLERGAN MEDICAL OPTICS
K924033	ALTEX MODEL UST-3000E	Nov 05, 1992	Substantially Equivalent	OPTRO-MECHANICS (USA) CORP.
K922595	MODIFIED SITE MACROBORE PHACO NEEDLE	Aug 31, 1992	Substantially Equivalent	CHIRON VISION CORP.
K921607	IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE	Jun 30, 1992	Substantially Equivalent	CHIRON VISION CORP.
K912904	MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM	Jun 11, 1992	Substantially Equivalent	MENTOR O & O, INC.
K921135	IOLAB POWER I.V. POLE	Jun 03, 1992	Substantially Equivalent	SITE MICROSURGICAL SYSTEMS, INC.
K915457	PHACO 20/20 SYSTEM I	Feb 24, 1992	Substantially Equivalent	INNOVATIVE MEDICAL SYSTEMS, INC.
K915456	PHACO 3000 LINEAR	Feb 12, 1992	Substantially Equivalent	INNOVATIVE MEDICAL SYSTEMS, INC.
K915118	PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE	Dec 27, 1991	Substantially Equivalent	IPAX, INC.
K914229	PHACO TIP	Dec 27, 1991	Substantially Equivalent	TRI-STAR OPHTHALMIC
K912902	PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE	Dec 17, 1991	Substantially Equivalent	SITE MICROSURGICAL SYSTEMS, INC.
K914172	KPE 230 AM	Oct 25, 1991	Substantially Equivalent	IPAX, INC.
K913530	LOOK VISCODISSECTOR	Oct 21, 1991	Substantially Equivalent	LOOK, INC.
K912739	SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE	Aug 28, 1991	Substantially Equivalent	SITE MICROSURGICAL SYSTEMS, INC.
K911808	GEMINI OPHTHALMIC SURGERY SYSTEM	Jun 25, 1991	Substantially Equivalent	ALCON LABORATORIES
K904612	I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)	Dec 26, 1990	Substantially Equivalent	MEDICAL TECHNICAL PRODUCTS
K904183	SITE PHACOEMULSIFICATION HANDPIECE	Dec 05, 1990	Substantially Equivalent	SITE MICROSURGICAL SYSTEMS, INC.
K904151	SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE	Dec 05, 1990	Substantially Equivalent	SITE MICROSURGICAL SYSTEMS, INC.
K902876	PHACOTRON SYSTEMS PLUS III PHACOEMULSIFIER ASPI.	Sep 18, 1990	Substantially Equivalent	INTRAOPTICS SURGICAL, INC.
K902798	AUTOMATED HYDROSONICS(TM)	Aug 28, 1990	Substantially Equivalent	ALCON SURGICAL, INC.
K900493	THE PRECISIONIST	Aug 28, 1990	Substantially Equivalent	PARADIGM MEDICAL, INC.
K902150	PIEZO HANDPIECE	Jul 05, 1990	Substantially Equivalent	UNITED SURGICAL CORP.
K901686	NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000	Jun 08, 1990	Substantially Equivalent	NIDEK, INC.
K894512	PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS	Oct 17, 1989	Substantially Equivalent	INTL. OPHTHALMIC INDUSTRIES CORP.
K894511	MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT	Oct 17, 1989	Substantially Equivalent	INTL. OPHTHALMIC INDUSTRIES CORP.
K892852	SITE PHACO PLUS INFUSION SLEEVE	Jun 08, 1989	Substantially Equivalent	SITE MICROSURGICAL SYSTEMS, INC.
K891161	VITRECTOMY PACK #J120	May 26, 1989	Substantially Equivalent	O.R. SPECIALTIES, INC.
K890825	JUMPER PACK #203	May 26, 1989	Substantially Equivalent	O.R. SPECIALTIES, INC.
K892911	SITE PERISTALTIC CASSETTE	May 17, 1989	Substantially Equivalent	SITE MICROSURGICAL SYSTEMS, INC.
K890635	CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.	May 09, 1989	Substantially Equivalent	COOPERVISION, INC.
K890080	PHACOEMULSIFIER MODEL 100	Apr 06, 1989	Substantially Equivalent	SONIC NEEDLE CORP.
K884241	STAAR PHACO XL SMALL INCISION SYSTEM	Feb 17, 1989	Substantially Equivalent	STAAR SURGICAL CO.
K883097	GV3000 PHACOEMULSIFIER/FRAGMENTER	Dec 06, 1988	Substantially Equivalent	D.O.R.C. INTL. B.V.
K883199	MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM	Sep 15, 1988	Substantially Equivalent	CHIRON VISION CORP.
K883099	SITE MACROBORE PHACO NEEDLE	Sep 15, 1988	Substantially Equivalent	SITE MICROSURGICAL SYSTEMS, INC.
K882103	SITE ULTRASONIC I/A PHACO NEEDLE	Jul 01, 1988	Substantially Equivalent	SITE MICROSURGICAL SYSTEMS, INC.
K881635	NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM	Jul 01, 1988	Substantially Equivalent	NOETIX, INC.
K880062	C-MATE #CMU 1001	Mar 07, 1988	Substantially Equivalent	O.R. SPECIALTIES, INC.
K874334	SOLOS SINGLE USE TITANIUM TIP	Jan 11, 1988	Substantially Equivalent	SOLOS OPHTHALMOLOGY
K872611	SOLOS EYESITE CAP SLEEVE	Aug 10, 1987	Substantially Equivalent	SOLOS OPHTHALMOLOGY
K871473	PART #860065 IA PAK & PART #860060 IA PAK	Aug 10, 1987	Substantially Equivalent	MEDICAL TECHNICAL PRODUCTS
K872362	FRIGITRONICS ACC-1000 CAPSULE CUTTER	Jul 27, 1987	Substantially Equivalent	FRIGITRONICS OF CONNECTICUT, INC.
K871854	IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS	Jul 27, 1987	Substantially Equivalent	COOPERVISION, INC.
K871485	SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE	Jun 03, 1987	Substantially Equivalent	SITE MICROSURGICAL SYSTEMS, INC.
K871649	CLASSIC 70 LENS	May 29, 1987	Substantially Equivalent	KOREA ASAHI OPTICAL CO., LTD.
K870671	PHACOTRON DAY PAK	Apr 06, 1987	Substantially Equivalent	UNITED SURGICAL CORP.
K870806	NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100	Mar 26, 1987	Substantially Equivalent	UNITED SURGICAL CORP.
K864726	I/A/KPE TIP	Jan 20, 1987	Substantially Equivalent	IPAX, INC.
K864301	SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD)	Dec 15, 1986	Substantially Equivalent	SITE MICROSURGICAL SYSTEMS, INC.
K864056	GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANT	Oct 31, 1986	Substantially Equivalent	GRIESHABER & CO.
K863444	GRIESHABER GLOBAL CONTROL TUBING SET	Oct 31, 1986	Substantially Equivalent	GRIESHABER & CO.
K863729	OPHTHALMIC FITLER MICRO CAPSULE	Oct 10, 1986	Substantially Equivalent	IPAX, INC.
K863209	US PLUS-PAK(R) SURGICAL SYSTEM	Sep 08, 1986	Substantially Equivalent	IPAX, INC.
K862777	MODEL A-8000 ULTRASONIC HANDPIECE CORD	Aug 11, 1986	Substantially Equivalent	ADVANCED MEDICAL TECHNOLOGY, INC.
K862021	PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM	Jun 23, 1986	Substantially Equivalent	ULTRAMED, INC.
K862064	ENTRAVISION EP-500 I/A ECCO PACK	Jun 19, 1986	Substantially Equivalent	ENTRAVISION, INC.
K862063	ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE	Jun 19, 1986	Substantially Equivalent	ENTRAVISION, INC.
K860957	DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT.	Jun 02, 1986	Substantially Equivalent	MEDICAL CORP. OF AMERICA
K860956	KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST.	Jun 02, 1986	Substantially Equivalent	MEDICAL CORP. OF AMERICA
K861060	SITE PHACO DISPOSABLE CASSETTE	May 06, 1986	Substantially Equivalent	SITE MICROSURGICAL SYSTEMS, INC.
K860989	SITE DISPOSABLE CASSETTE	May 06, 1986	Substantially Equivalent	MICROSURGICAL SYSTEMS, INC.
K860770	AM-100 I/A AMPAC	Apr 21, 1986	Substantially Equivalent	DRAVON MEDICAL, INC.
K854375	COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR	Dec 27, 1985	Substantially Equivalent	COOPERVISION, INC.
K854225	ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS	Dec 27, 1985	Substantially Equivalent	ADVANCED MEDICAL TECHNOLOGY, INC.
K854116	PHACO PACKS, 1A PACKS & PACK COMPONENTS	Dec 27, 1985	Substantially Equivalent	MEDICAL CORP. OF AMERICA
K844373	O.M.S. ULTRA-PHACO	Dec 19, 1985	Substantially Equivalent	OPTICAL MICRO SYSTEMS, INC.
K853883	TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR	Oct 08, 1985	Substantially Equivalent	MEDICAL CORP. OF AMERICA
K853189	CREAT BRAND I/A PACK CREAT BRAND PHACO PACK	Sep 24, 1985	Substantially Equivalent	AESTHETECH CORP.
K853070	COOPER VISION SYSTEM VI U/S MODULE	Aug 20, 1985	Substantially Equivalent	COOPERVISION, INC.
K852208	PHACO-BAC STOP FILTER KIT	Aug 20, 1985	Substantially Equivalent	STAAR SURGICAL CO.
K851674	PHAKOSYSTEMS MODEL CES 4100	Aug 05, 1985	Substantially Equivalent	PHAKOSYSTEMS, INC.
K851211	PHACO PAK I	Jun 05, 1985	Substantially Equivalent	UNITED SONICS, INC.
K851298	MID LABS MVSXI	May 31, 1985	Substantially Equivalent	UNITED SONICS, INC.
K851212	UNITED SONICS PACO SYSTEM MODEL 3000	May 31, 1985	Substantially Equivalent	UNITED SONICS, INC.
K851210	UNITED SONICS PHACO MODULE, DF-35	May 31, 1985	Substantially Equivalent	UNITED SONICS, INC.
K851209	CILCO/UNITED SONICS PHACE PF-9000	May 31, 1985	Substantially Equivalent	UNITED SONICS, INC.
K843276	IOCARE CONVERTER KIT	May 09, 1985	Substantially Equivalent	CHIRON VISION CORP.
K850532	ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK	Apr 15, 1985	Substantially Equivalent	ATLANTIC OPTICAL SYSTEMS, INC.
K850275	KCP PAK #2 CONVENIENCE PACK MODIFICATION	Apr 15, 1985	Substantially Equivalent	COOPERVISION, INC.
K850149	KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA	Apr 15, 1985	Substantially Equivalent	COOPERVISION, INC.
K850148	KCP PAK CONVENIENCE PACK	Apr 15, 1985	Substantially Equivalent	COOPERVISION, INC.
K851009	INFUSION SLEEVE - OPHTHALMIC	Apr 03, 1985	Substantially Equivalent	MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
K850578	PHACOEMULSIFICATION TIP	Apr 03, 1985	Substantially Equivalent	ULTRAMED, INC.
K850900	PHACO-BAC STOP KIT	Mar 29, 1985	Substantially Equivalent	STAAR SURGICAL CO.
K850899	I/A BAC STOP KIT	Mar 29, 1985	Substantially Equivalent	STAAR SURGICAL CO.
K843487	VISITEC OPHTHALMIC FLUID DISTRIB- SET	Mar 13, 1985	Substantially Equivalent	VISITEC CO.
K843319	CILCO I/A SURGICAL PACK	Feb 14, 1985	Substantially Equivalent	CILCO, INC.
K844666	SITE ULTRASONIC EMULSIFICATION MODULE OP	Dec 27, 1984	Substantially Equivalent	CHIRON VISION CORP.
K844150	MEDICAL OPTICS PHACOEMULSIFICATION KIT	Dec 11, 1984	Substantially Equivalent	AMERICAN MEDICAL OPTICS
K842945	COOPERVISION SYSTEM VI	Dec 11, 1984	Substantially Equivalent	COOPERVISION, INC.
K843386	MENDEZ U/S CYSTOTOME	Nov 27, 1984	Substantially Equivalent	COOPERVISION, INC.
K843278	IOCARE ULTRASONIC TITANIUM TIPS	Nov 27, 1984	Substantially Equivalent	CHIRON VISION CORP.
K843277	IOCARE PHACOEMULSIFICATION PACK	Nov 27, 1984	Substantially Equivalent	CHIRON VISION CORP.
K843275	IOCARE IRRIGATION/ASPIRATION PACK	Nov 27, 1984	Substantially Equivalent	CHIRON VISION CORP.
K842979	CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA	Nov 27, 1984	Substantially Equivalent	COOPERVISION, INC.
K840181	CATAREX/ULTRASONICS KIT	Oct 05, 1984	Substantially Equivalent	CALLIOPE CORP.
K840063	CATAREX VITRECUTTER I/A DISPOS. CUT	Oct 05, 1984	Substantially Equivalent	CALLIOPE CORP.
K842458	SITE SIMCOE STYLE I/A HANDPIECE	Aug 15, 1984	Substantially Equivalent	CHIRON VISION CORP.
K840495	MANUAL IRRIGATING/ASPIRATING UNIT	Jun 19, 1984	Substantially Equivalent	ALLTEK, INC.
K840695	PHACOEMULSIFICATION KITS	May 22, 1984	Substantially Equivalent	INNOVATIVE SURGICAL PRODUCTS INC.
K840965	SITE COAXIAL I/A HANDPIECE 30 TIP	May 09, 1984	Substantially Equivalent	CHIRON VISION CORP.
K834340	IOCARE IRRIGATION & ASPIRATION PACK	Apr 05, 1984	Substantially Equivalent	CHIRON VISION CORP.
K841072	IRRIGATION, ASPIRATION TUBING SETS	Mar 29, 1984	Substantially Equivalent	INNOVATIVE SURGICAL PRODUCTS INC.
K834543	OCUCARE ULTRASOUND TIP & FREEDOM PACK	Mar 16, 1984	Substantially Equivalent	INTERMEDICS INTRAOCULAR, INC.
K834537	MICRO VIT FRAGMENTATION SYSTEM	Mar 16, 1984	Substantially Equivalent	MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
K834453	PHACO FRAGMENTOR GT-1	Mar 16, 1984	Substantially Equivalent	FIBRA SONICS, INC.
K834261	PLASTIC OPTICAL LENS M-110	Mar 16, 1984	Substantially Equivalent	U-MOLDE SYSTEMS, INC.
K833465	DISPOSABLE FIBER OPTIC ILLUMINATOR	Mar 15, 1984	Substantially Equivalent	COOPERVISION, INC.
K833962	KPE PLUS-PAK SURGICAL SYSTEM	Mar 12, 1984	Substantially Equivalent	IPAX, INC.
K833961	I/A PLUS PAK SURGICAL SYSTEM	Mar 12, 1984	Substantially Equivalent	IPAX, INC.
K833783	DISPOS. I/A & IRRIGATION HANDPIECES	Mar 05, 1984	Substantially Equivalent	COOPERVISION, INC.
K833642	PHAKO SYSTEMS VIA 2000	Mar 05, 1984	Substantially Equivalent	PHAROSYSTEMS, INC.
K833784	DISPOSABLE I/A HANDPIECE	Feb 21, 1984	Substantially Equivalent	COOPERVISION, INC.
K833405	IRRIGATION ASPIRATION KIT	Jan 06, 1984	Substantially Equivalent	AMERICAN MEDICAL OPTICS
K833800	BEECHER 20 GA. PROBE	Jan 04, 1984	Substantially Equivalent	BEECHER MEDICAL DIAGNOSTIC INSTRUMENTATION
K833064	STORZ EXTRA	Jan 04, 1984	Substantially Equivalent	STORZ INSTRUMENT CO.
K832529	M.S.D. ASPIRATOR	Jan 04, 1984	Substantially Equivalent	MEDICAL SURGICAL DESIGNS
K834161	UNIVERSAL PAC	Dec 28, 1983	Substantially Equivalent	AMERICAN SURGICAL CO., INC.
K834159	PHACOTRON PLUS	Dec 28, 1983	Substantially Equivalent	AMERICAN SURGICAL CO., INC.
K834158	EXTRA SENSORY PLUS	Dec 28, 1983	Substantially Equivalent	AMERICAN SURGICAL CO., INC.
K833697	EXTRA SENSORY PAK-DISPOS. ACCESS	Dec 28, 1983	Substantially Equivalent	AMERICAN SURGICAL CO., INC.
K833617	EXTRA PLUS TM	Dec 28, 1983	Substantially Equivalent	AMERICAN SURGICAL CO., INC.
K832980	VXTRA OCUTOME KIT	Oct 19, 1983	Substantially Equivalent	VXTRA CORP.
K832997	EPA AUTOMATED INFUSION POLE	Oct 04, 1983	Substantially Equivalent	MIAMI EYE TECHNOLOGY, INC.
K832413	SIAS IRRIGATION/ASPIRATION SYSTEM	Oct 04, 1983	Substantially Equivalent	CLARK POOL & ASSOC.
K832559	OCUCARE FREEDOM PACK	Sep 29, 1983	Substantially Equivalent	OCULAR INNOVATIONS, INC.
K832424	ENVISION G31 P.E. PAK	Sep 12, 1983	Substantially Equivalent	ENVISION, INC.
K832423	ENVISION G21 I/A ENPAK	Sep 12, 1983	Substantially Equivalent	ENVISION, INC.
K831701	UNIVERSAL PACK	Jul 12, 1983	Substantially Equivalent	ATLANTIC OPTICAL SYSTEMS, INC.
K831836	EPSILON ULTRASONIC TIP	Jun 30, 1983	Substantially Equivalent	COOPERVISION, INC.
K831172	ULTRAKIT	Jun 08, 1983	Substantially Equivalent	STAAR SURGICAL CO.
K830812	ALPHAMEDIX I/A HAND-PIECE, 500-001	Jun 08, 1983	Substantially Equivalent	ALPHAMEDIX, INC.
K830902	OCUCARE PACK	May 16, 1983	Substantially Equivalent	OCULAR INNOVATIONS, INC.
K823088	ASPITRON	Apr 06, 1983	Substantially Equivalent	INTL. OPHTHALMIC INDUSTRIES CORP.
K830474	IV STAND	Apr 05, 1983	Substantially Equivalent	TEKNAR, INC.
K830385	IRRIGATION/ASPIRATION KIT	Apr 05, 1983	Substantially Equivalent	VXTRA CORP.
K830379	PHAKO KIT	Apr 05, 1983	Substantially Equivalent	VXTRA CORP.
K812126	ULTRASONIC TIPS	Sep 18, 1981	Substantially Equivalent	COOPERVISION, INC.
K802381	LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.	Dec 17, 1980	Substantially Equivalent	FIBRA SONICS, INC.
K782141	LEVIGATOR, KEELER PHOKO	Jan 26, 1979	Substantially Equivalent	KEELER OPTICAL PRODUCTS LTD.
K771644	FRAGMATOME MODEL 820	Sep 26, 1977	Substantially Equivalent	BERKELEY BIO-ENGINEERING

FEI Numbers

This FDA classification entry is associated with 71 FEI numbers. Click on an entry to view related FDA registrations.

1000114111: 152 registrations

1000117172: 10 registrations

1000117501: 20 registrations

1000119053: 24 registrations

1000119305: 139 registrations

1000120314: 16 registrations

1000121498: 28 registrations

1000125771: 23 registrations

1000136478: 184 registrations

1000142667: 15 registrations

1000161215: 13 registrations

1000219637: 355 registrations

1000221463: 11 registrations

1000306431: 841 registrations

1000518731: 132 registrations

1000640985: 2 registrations

1036836: 105 registrations

1047843: 371 registrations

1317547: 20 registrations

1317628: 309 registrations

1526711: 131 registrations

1720929: 257 registrations

1920664: 46 registrations

1928237: 782 registrations

2025303: 3 registrations

2126666: 73 registrations

2246552: 325 registrations

2523835: 30 registrations

2648045: 124 registrations

3000226659: 20 registrations

3001236277: 474 registrations

3002532015: 8 registrations

3002681132: 136 registrations

3002806863: 26 registrations

3002807040: 108 registrations

3002807111: 309 registrations

3002807944: 12 registrations

3003015552: 444 registrations

3003058448: 327 registrations

3003263857: 27 registrations

3003365815: 17 registrations

3003398873: 12 registrations

3003481798: 37 registrations

3003691824: 14 registrations

3005012805: 178 registrations

3006695864: 23 registrations

3006946276: 82 registrations

3007007790: 84 registrations

3007344957: 42 registrations

3007648309: 6 registrations

3009026057: 14 registrations

3009337401: 60 registrations

3009617712: 165 registrations

3009732568: 148 registrations

3010047402: 36 registrations

3010162782: 16 registrations

3010208880: 25 registrations

3010220595: 187 registrations

3010291427: 90 registrations

3012123033: 4 registrations

3012132406: 2 registrations

3012236936: 46 registrations

3013497605: 1 registration

3014256632: 12 registrations

3015456951: 20 registrations

3015528097: 6 registrations

3016245399: 31 registrations

3016565705: 10 registrations

3019924: 35 registrations

3029990829: 20 registrations

3033485955: 11 registrations

Registration Numbers

This FDA classification entry is associated with 71 registration numbers. Click on an entry to view related FDA registrations.

1036836: 105 registrations

1047843: 371 registrations

1054713: 152 registrations

1058584: 355 registrations

1226011: 8 registrations

1313525: 309 registrations

1317547: 20 registrations

1319429: 16 registrations

1319660: 184 registrations

1424263: 444 registrations

1526711: 131 registrations

1644019: 20 registrations

1649518: 474 registrations

1650907: 136 registrations

1720929: 257 registrations

1722139: 10 registrations

1920664: 46 registrations

1928237: 782 registrations

1932180: 139 registrations

1932402: 24 registrations

2025303: 3 registrations

2028159: 23 registrations

2029275: 841 registrations

2030598: 132 registrations

2032098: 327 registrations

2085081: 15 registrations