Product Code: HQE FDA class 2 21 CFR 886.4150

Instrument, Vitreous Aspiration And Cutting, Ac-Powered

Ophthalmic

An AC-Powered Vitreous Aspiration and Cutting Instrument is an ophthalmic surgical device used during vitreoretinal surgery to aspirate, cut, and remove the vitreous gel from the posterior segment of the eye, enabling access to the retina for repair of retinal detachments, macular holes, and other posterior segment conditions. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQE and is regulated under 21 CFR 886.4150, within the Ophthalmic medical specialty. It is eligible for third-party review.

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510(k)s

149

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: HQE
Device Class: FDA class 2
Regulation Number: 886.4150
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 149 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K212763	UniVit HE, UniVit UHS	Aug 10, 2022	Substantially Equivalent	Visioncare Devices, LLC
K170183	Cetus system, Cetus probe	Sep 27, 2017	Substantially Equivalent	A.R.C Laser GmbH
K153168	Bi-Blade Vitrectomy Cutter	Apr 29, 2016	Substantially Equivalent	Medical Instrument Development Laboratories
K141065	CONSTELLATION VISION SYSTEM	Aug 22, 2014	Substantially Equivalent	Alcon Research, Ltd.
K121675	VERSAVIT	Jun 21, 2012	Substantially Equivalent	Synergetics, Inc.
K120170	PROCARE PLUS VITRECTOMY SYSTEM	May 30, 2012	Substantially Equivalent	Visioncare Devices, Inc.
K102222	ULTIMATE VIT ENHAMCER (UVE)	Apr 08, 2011	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K033390	COLIBRI DISPOSABLE VITRECTOMY CUTTER	Nov 04, 2003	Substantially Equivalent	Microworld Medical Instruments, Inc.
K030948	VMATE MODEL VMM1000	Jun 17, 2003	Substantially Equivalent	Howard Instruments, Inc.
K023939	VELOCITY ADVANTAGE	Apr 17, 2003	Substantially Equivalent	Visioncare Devices, Inc.
K020911	MID LABS AUTONOMOUS VIT ENHANCER (AVE)	Apr 29, 2002	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K010082	D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM	Mar 12, 2001	Substantially Equivalent	Dutch Ophthalmic USA, Inc.
K992943	VIT ENHANCER	Dec 10, 1999	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K990292	I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN	Nov 19, 1999	Substantially Equivalent	Ophthalmic Consultants, Inc.
K983797	D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM	Mar 03, 1999	Substantially Equivalent	Dutch Ophthalmic USA, Inc.
K980400	PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10	Apr 30, 1998	Substantially Equivalent	Peregrine Surgical , Ltd.
K980399	PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20	Apr 30, 1998	Substantially Equivalent	Peregrine Surgical , Ltd.
K980488	STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM	Mar 23, 1998	Substantially Equivalent	Storz Instrument Co.
K970670	REUSABLE VITRECTOMY PROBE	May 06, 1997	Substantially Equivalent	Altex Vision
K970673	DISPOSABLE VITRECTOMY PROBE	May 05, 1997	Substantially Equivalent	Altex Vision
K964743	STORZ E8010 ERGOTEC/PREMIERE ADAPTOR	Feb 03, 1997	Substantially Equivalent	Storz Instrument Co.
K961738	VIT COMMANDER SYSTEM	Nov 25, 1996	Substantially Equivalent	Scieran Technologies, Inc.
K960061	STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE	Sep 18, 1996	Substantially Equivalent	Storz Instrument Co.
K961078	AUTOMATED VITRECTOMY DEVICE	Jun 14, 1996	Substantially Equivalent	Promex, Inc.
K954816	STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX	Mar 04, 1996	Substantially Equivalent	Storz Instrument Co.
K953576	STORZ DP4505 VITREOUS MEMBRANE DISSECTOR	Sep 14, 1995	Substantially Equivalent	Storz Instrument Co.
K953575	STORZ MVS-3201 VITRECTOMY PROBE PACK	Sep 14, 1995	Substantially Equivalent	Storz Instrument Co.
K950852	CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP)	May 19, 1995	Substantially Equivalent	H.S. Intl. Co., Inc.
K950799	PRO-VIT	Apr 28, 1995	Substantially Equivalent	M. Imonti and Associates Inc.,
K946135	INFINITECH ASPIRATING LASER PROBE	Apr 18, 1995	Substantially Equivalent	Surgical Technologies, Inc.
K946181	INFINITECH SOFT TIP FLUTE NEEDLE	Mar 14, 1995	Substantially Equivalent	Surgical Technologies, Inc.
K934600	MICRODRIVE	Jul 27, 1994	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K936302	NIDEK MODEL VT-4000, MODIFICATION	Jul 15, 1994	Substantially Equivalent	Nidek, Inc.
K940391	PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE	Jun 08, 1994	Substantially Equivalent	Peregrine Surgical , Ltd.
K940746	VIT CUTTER MODEL 94	Jun 06, 1994	Substantially Equivalent	Visioncare Devices, Inc.
K932669	SUPRA-VIT(TM)	Jun 03, 1994	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K930842	THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE	May 03, 1994	Substantially Equivalent	Grieshaber & Co.
K933907	STORZ FIBEROPTIC PICK MANIPULATOR	Mar 07, 1994	Substantially Equivalent	Storz Instrument Co.
K932668	OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER	Feb 23, 1994	Substantially Equivalent	Synergetics, Inc.
K934204	INTERTIP INFUSION SET	Feb 07, 1994	Substantially Equivalent	Oasis Medical, Inc.
K933984	STORZ FIBEROPTIC REVERSE CUTTING KNIFE	Jan 25, 1994	Substantially Equivalent	Storz Instrument Co.
K933208	BARE-FIBER ENDOILLUMINATOR	Dec 14, 1993	Substantially Equivalent	Surgical Technologies, Inc.
K924353	NIDEK MODEL VST-4000	Mar 29, 1993	Substantially Equivalent	Nidek, Inc.
K924222	MID LABS, INC. VIT MATE	Jan 27, 1993	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K924604	STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV	Nov 27, 1992	Substantially Equivalent	Storz Instrument Co.
K922355	POLLY'S VITREOUS SCISSORS J-225-S	Aug 18, 1992	Substantially Equivalent	O.R. Specialties, Inc.
K921758	STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM	Jul 16, 1992	Substantially Equivalent	Storz Instrument Co.
K921460	STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS	Jul 02, 1992	Substantially Equivalent	Storz Instrument Co.
K920718	DISPOSABLE POSTERIOR MICROSCISSORS	May 18, 1992	Substantially Equivalent	Storz Instrument Co.
K920582	180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.	May 08, 1992	Substantially Equivalent	Site Microsurgical Systems, Inc.
K915745	D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE	Mar 13, 1992	Substantially Equivalent	Storz Instrument Co.
K913504	STORZ MICRO CUTTER 25 GAUGE PACK	Feb 21, 1992	Substantially Equivalent	Storz
K913261	DWYER EYE SYSTEMS ASPIRATION UNIT	Jan 30, 1992	Substantially Equivalent	Spectracare, Inc.
K912384	DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE	Dec 24, 1991	Substantially Equivalent	Nidek, Inc.
K914038	POLLY'S CUTTER J-225	Dec 09, 1991	Substantially Equivalent	O.R. Specialties, Inc.
K913837	MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM	Nov 05, 1991	Substantially Equivalent	Vision Medical, Inc.
K914221	KPE 220 TS, NONSTERILE	Oct 25, 1991	Substantially Equivalent	Ipax, Inc.
K912253	LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING	Aug 07, 1991	Substantially Equivalent	Ocular Instruments, Inc.
K911998	MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM	Jul 26, 1991	Substantially Equivalent	Allergan Medical Optics
K910973	DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE	Apr 26, 1991	Substantially Equivalent	Surgical Technologies, Inc.
K904909	I/A VITROPHAGE MODEL YPR 2001	Jan 28, 1991	Substantially Equivalent	Visioncare Devices, Inc.
K895813	GLAUCOMA MECHANICAL TREPHINE	Apr 30, 1990	Substantially Equivalent	Trek Medical Products, Inc.
K896943	SITE DISPOSABLE CUTTER AND ACCESSORIES	Mar 08, 1990	Substantially Equivalent	Site Microsurgical Systems, Inc.
K894248	CONVERTER SYSTEM	Feb 27, 1990	Substantially Equivalent	Mira, Inc.
K896754	I/A HANDPIECE	Jan 11, 1990	Substantially Equivalent	Advanced Surgical Products, Inc.
K896305	MULTI-USE I/A HANDPIECE	Dec 18, 1989	Substantially Equivalent	Advanced Surgical Products, Inc.
K894278	STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS	Aug 11, 1989	Substantially Equivalent	Storz Instrument Co.
K890195	JAMES SURGICAL SYSTEM J1000	Aug 03, 1989	Substantially Equivalent	O.R. Specialties, Inc.
K891601	POWER OPERATED AND CONTROLLED VITREOUS SCISSORS	May 23, 1989	Substantially Equivalent	Mira, Inc.
K884557	ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE	May 12, 1989	Substantially Equivalent	Advanced Surgical Products, Inc.
K890622	SURG-E-TROL SYSTEM I AND SYSTEM II	May 04, 1989	Substantially Equivalent	Mentor O & O, Inc.
K890300	INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE	Apr 17, 1989	Substantially Equivalent	CooperVision, Inc.
K890133	OCULAR CONNECTION MACHINE(TM)	Apr 12, 1989	Substantially Equivalent	Innovision Medical, Inc.
K890544	SHAPIRO CUTTER	Feb 28, 1989	Substantially Equivalent	H.S. Intl. Co., Inc.
K884556	DREYER CURVED ENDOILLUMINATOR	Feb 28, 1989	Substantially Equivalent	Advanced Surgical Products, Inc.
K885196	LASER INDIRECT OPHTHALMOSCOPE (LIO)	Jan 11, 1989	Substantially Equivalent	Coherent Medical Group
K884043	GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE	Nov 16, 1988	Substantially Equivalent	Grieshaber & Co.
K883926	.2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND.	Nov 15, 1988	Substantially Equivalent	Site Microsurgical Systems, Inc.
K883975	DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.	Oct 25, 1988	Substantially Equivalent	Site Microsurgical Systems, Inc.
K883605	MODIFIED REUSABLE SITE FIBER OPTIC CABLE	Oct 25, 1988	Substantially Equivalent	Site Microsurgical Systems, Inc.
K881519	VAC-G (GUILLOTINE VITRECTOR)	Sep 08, 1988	Substantially Equivalent	B&B Medical Assoc., Inc.
K881520	VAC (OSCILLATING VITRECTOR)	Sep 07, 1988	Substantially Equivalent	B&B Medical Assoc., Inc.
K880943	MICROLINE CAT #100	May 26, 1988	Substantially Equivalent	Microline Pentax, Inc.
K881927	PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES	May 25, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K880929	NIDEK CV-4000	May 25, 1988	Substantially Equivalent	Nidek, Inc.
K880968	MODEL 2001 PHACOEMULSIFIER ASPIRATOR	Apr 19, 1988	Substantially Equivalent	Mcghan Instrumed Corp.
K872312	MODEL 3000 OPHTHALMIC SURGICAL SYSTEM	Jul 15, 1987	Substantially Equivalent	Allergan Humphrey
K871871	SERIES TEN THOUSAND OCUTOME	Jun 11, 1987	Substantially Equivalent	CooperVision, Inc.
K871375	SITE PERISTALTIC MODULE SYSTEM	May 07, 1987	Substantially Equivalent	Site Microsurgical Systems, Inc.
K870775	ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE	Mar 26, 1987	Substantially Equivalent	Entravision, Inc.
K870068	ASPIRATION REVERSAL CONTROL (ARC) MODULE	Feb 12, 1987	Substantially Equivalent	Optical Micro Systems, Inc.
K864035	VES-10 INTRAOCULAR SCISSORS DRIVE	Dec 15, 1986	Substantially Equivalent	Trek Medical Products, Inc.
K862943	SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE	Aug 21, 1986	Substantially Equivalent	Site Microsurgical Systems, Inc.
K862188	IRRIGATION & ASPIRATION/VITRECTOMY DEVICE	Aug 21, 1986	Substantially Equivalent	Coburn Optical Ind., Inc.
K862343	VACUUM HANDLE MODEL I/A - 1	Jul 11, 1986	Substantially Equivalent	Cutler Medical Instruments
K861565	SERIES TEN THOUSAND COMPACT	Jul 11, 1986	Substantially Equivalent	CooperVision, Inc.
K861380	SERIES TEN THOUSAND MASTER	Jul 11, 1986	Substantially Equivalent	CooperVision, Inc.
K860891	AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE	Apr 21, 1986	Substantially Equivalent	Intra-Optics Labs. C/O Newman Assoc.
K860014	SYSTEMS PLUS	Mar 05, 1986	Substantially Equivalent	United Surgical Corp.
K854871	MICRO SURGICAL SYSTEM	Feb 07, 1986	Substantially Equivalent	Mira, Inc.
K854868	I/A - VFE SYSTEM II	Feb 07, 1986	Substantially Equivalent	Mira, Inc.
K834162	VIT PAC	Feb 07, 1986	Substantially Equivalent	American Surgical Co., Inc.
K834160	VITREONIC PLUS	Feb 07, 1986	Substantially Equivalent	American Surgical Co., Inc.
K854508	STORZ DAISY	Feb 04, 1986	Substantially Equivalent	Storz Instrument Co.
K853430	STORZ IAS DISPOSABLE PACK	Dec 16, 1985	Substantially Equivalent	Storz Instrument Co.
K853961	VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100	Dec 13, 1985	Substantially Equivalent	Visitec Co.
K853457	COBURN I/A SYSTEM	Oct 15, 1985	Substantially Equivalent	Coburn Optical Ind., Inc.
K853382	MAID MENTOR ASPIRATION/IRRIGATION DEVRO	Oct 04, 1985	Substantially Equivalent	Mentor O & O, Inc.
K853308	KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000	Oct 04, 1985	Substantially Equivalent	Frigitronics of Connecticut, Inc.
K851936	STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT	Aug 20, 1985	Substantially Equivalent	Staar Surgical Co.
K853135	VISITEC 2 MICRON FLUID FILTER	Aug 09, 1985	Substantially Equivalent	Visitec Co.
K852271	CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001	Aug 09, 1985	Substantially Equivalent	CooperVision, Inc.
K851610	COMBINED MVS SYSTEMS	Jul 22, 1985	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K851272	VERSAPHAGE	Jul 05, 1985	Substantially Equivalent	Alphamedix, Inc.
K843594	AIRVIT MODEL 8500	Apr 11, 1985	Substantially Equivalent	Lasermed Corp.
K850857	I/A HANDPIECE	Mar 29, 1985	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K844715	VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY	Jan 22, 1985	Substantially Equivalent	Optical Micro Systems, Inc.
K843391	INFUSION ASPIRATION VITRECTOMY SYS	Dec 19, 1984	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K842793	MVS XII	Dec 19, 1984	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K844510	OMS SCISSORS	Dec 11, 1984	Substantially Equivalent	Optical Micro Systems, Inc.
K844374	O.M.S. GUILLOTINE CUTTER	Dec 11, 1984	Substantially Equivalent	Optical Micro Systems, Inc.
K842188	MULTIPLE-LENS, SPECTACLES, CUSTOM	Dec 11, 1984	Substantially Equivalent	Gold Cadillac Co.
K843041	HESLIN DISPOS. TUBING SET	Nov 21, 1984	Substantially Equivalent	Innovative Surgical Products, Inc.
K842471	AUTOMATED INTRAOCULAR SCISSORS	Nov 21, 1984	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K841738	AMER. SURGICAL CORP. EXTRA PLUS PAK	Oct 05, 1984	Substantially Equivalent	American Surgical Co., Inc.
K842197	AMERICAN MEDICAL OPTICS I/A KIT- IRRIG	Oct 01, 1984	Substantially Equivalent	American Medical Optics
K834155	UNIVERSAL PACK	Jun 19, 1984	Substantially Equivalent	Atlantic Optical Systems, Inc.
K834437	KEATES IRRIGATION/ASPIRATION/VITREOUS	Mar 30, 1984	Substantially Equivalent	Frigitronics of Connecticut, Inc.
K832703	ARGON LASER SYS-MODEL 5000	Jan 30, 1984	Substantially Equivalent	Cooper Medical Corp.
K833371	DISPOSABLE OCUTOME PROBE	Jan 04, 1984	Substantially Equivalent	CooperVision, Inc.
K834163	ULTRAVIT	Dec 28, 1983	Substantially Equivalent	American Surgical Co., Inc.
K832446	CATAREX DIAP. EXTRACAPSULAR CATARACT	Oct 19, 1983	Substantially Equivalent	Calliope Corp.
K832235	DISPOSABLE VITRECTOMY HANDPIECE	Sep 29, 1983	Substantially Equivalent	Innovative Surgical Products, Inc.
K831584	BAILEY ASPIRATOR/IRRIGATOR	Aug 12, 1983	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K830037	EXTENSION HANDLE FOR ACUTOME PROBE	Apr 06, 1983	Substantially Equivalent	Precision Medical Instruments, Inc.
K830216	DORC COMPACT MICRO SURGICAL SYSTEM	Mar 09, 1983	Substantially Equivalent	Jedmed Instrument Co.
K822220	COOPER VISION I/A SYSTEM III MODEL 1500	Oct 06, 1982	Substantially Equivalent	CooperVision, Inc.
K820933	CILCO I/A HANDPIECE	Jun 14, 1982	Substantially Equivalent	Cilco, Inc.
K820008	VERSATOME I	Feb 22, 1982	Substantially Equivalent	Alphamedix, Inc.
K820026	VITRE CON	Feb 05, 1982	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K813274	BLOOD POOL & SUBVETINAL FLUID ASPIRATOR	Feb 05, 1982	Substantially Equivalent	Optical Micro Systems, Inc.
K812857	CHARLES MICRO PROBE	Feb 05, 1982	Substantially Equivalent	Mid Laboratories, Inc.
K813500	OMS INFUSION-ASPIRATION HANDLE	Feb 04, 1982	Substantially Equivalent	Optical Micro Systems, Inc.
K813389	ULTRASONIC FRAGMENTOR	Feb 04, 1982	Substantially Equivalent	Fibra Sonics, Inc.
K801850	CHARLES PNEUMATIC INTRAOCULAR SCISSORS	Sep 16, 1980	Substantially Equivalent	Cooper Medical Devices Corp.
K800110	X-FLO	Feb 06, 1980	Substantially Equivalent	Contemporary Surgical Systems, Inc.
K791212	VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG	Aug 10, 1979	Substantially Equivalent	Precision Medical Instruments, Inc.
K781471	PNEUMATIC VITRECTOMY CONTROL UNIT	Nov 08, 1978	Substantially Equivalent	Helfgott Medical Instruments
K771711	BIOTOME	Sep 28, 1977	Substantially Equivalent	Berkeley Bio-Engineering