Product Code: MPA FDA class 2 21 CFR 876.1500

Endoilluminator

Gastroenterology, Urology

The Endoilluminator is a surgical device used during vitreoretinal surgery that provides illumination inside the eye, enabling surgeons to visualize intraocular structures during procedures such as vitrectomy. Classified as FDA Class 2 under 21 CFR 876.1500 in the Gastroenterology and Urology specialty, it requires 510(k) premarket notification and is eligible for third-party review. The product code is MPA, reviewed by the Ophthalmic panel.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MPA
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 40 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242184	Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);	Dec 04, 2024	Substantially Equivalent	Alcon Laboratories, Inc.
K233653	Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)	Aug 05, 2024	Substantially Equivalent	Peregrine Surgical, LLC
K221872	ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System	Mar 30, 2023	Substantially Equivalent	Nova Eye Inc. (Business Name Nova Eye Medical)
K202670	Nam illumination probe with chopper	Aug 20, 2021	Substantially Equivalent	Oculight , Ltd.
K151604	23ga Chandelier Illuminator, 25ga Chandelier Illuminator	Sep 11, 2015	Substantially Equivalent	Peregrine Surgical , Ltd.
K143123	Synergetics PHOTON EX	Feb 24, 2015	Substantially Equivalent	Synergetics
K080067	ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER	Jul 18, 2008	Substantially Equivalent	Iscience Interventional
K062895	XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII	Oct 13, 2006	Substantially Equivalent	Dutch Ophthalmic Research Center International BV
K062259	ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100	Aug 15, 2006	Substantially Equivalent	Iscience Surgical
K041108	ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA	Jun 22, 2004	Substantially Equivalent	Iscience Surgical Corporation
K032598	SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE	Nov 24, 2003	Substantially Equivalent	Synergetics, Inc.
K000252	INSIGHT 4000 ENDOSCOPE	Oct 17, 2000	Substantially Equivalent	Insight Instruments Mfg., Inc.
K000416	TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001	May 08, 2000	Substantially Equivalent	Retinalabs.Com
K980797	PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR	May 19, 1998	Substantially Equivalent	Peregrine Surgical , Ltd.
K980530	PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13	May 12, 1998	Substantially Equivalent	Peregrine Surgical , Ltd.
K980027	PEREGRINE SHIELDED DIFFUSION PROBE	Mar 31, 1998	Substantially Equivalent	Peregrine Surgical , Ltd.
K980025	PEREGRINE TAPERED DIFFUSION PROBE	Mar 31, 1998	Substantially Equivalent	Peregrine Surgical , Ltd.
K973229	D.O.R.C. HEXON ILLUMINATION SYSTEM	Nov 25, 1997	Substantially Equivalent	Dutch Ophthalmic USA, Inc.
K973293	SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR	Nov 18, 1997	Substantially Equivalent	Vaughan Weeks
K973290	SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK	Nov 14, 1997	Substantially Equivalent	Vaughan Weeks
K973757	D.O.R.C. SOLUX LIGHT SOURCE	Nov 07, 1997	Substantially Equivalent	Dutch Ophthalmic USA, Inc.
K971679	I-SCOPE OPHTHALMIC ENDOSCOPE	Jun 25, 1997	Substantially Equivalent	Ophthalmic Technologies, Inc.
K970882	ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)	Jun 24, 1997	Substantially Equivalent	American Medical Devices, Inc.
K964005	SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE	Jun 09, 1997	Substantially Equivalent	Synergetics, Inc.
K970875	ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)	May 20, 1997	Substantially Equivalent	American Medical Devices, Inc.
K964553	MBI CO-AXIAL ILLUMINATED RETINAL PICK	May 13, 1997	Substantially Equivalent	M.B. Industries, Inc.
K964405	MBI ILLUMINATED RETINAL PICK	May 13, 1997	Substantially Equivalent	M.B. Industries, Inc.
K971338	SYNTEC, INC. DISPOSABLE BARE END FIBER	May 06, 1997	Substantially Equivalent	Syntec, Inc.
K970878	ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT	May 06, 1997	Substantially Equivalent	American Medical Devices, Inc.
K964555	VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)	Mar 31, 1997	Substantially Equivalent	Vitrotec, Inc.
K963417	VITLITE (TR7700)	Dec 20, 1996	Substantially Equivalent	Escalon Trek Medical
K961036	MBI FIBEROPTIC ENDO-ILLUMINATOR	Jul 15, 1996	Substantially Equivalent	M.B. Industries, Inc.
K960007	STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR	Mar 26, 1996	Substantially Equivalent	Storz
K952585	GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR	Jan 05, 1996	Substantially Equivalent	Gamp & Assoc.
K952581	GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR	Jan 05, 1996	Substantially Equivalent	Gamp & Assoc.
K951627	INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM	Oct 19, 1995	Substantially Equivalent	Infinitech, Inc.
K946136	INFINITECH LIGHTED INFUSION CANNULA	Oct 02, 1995	Substantially Equivalent	Surgical Technologies, Inc.
K952586	GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR	Sep 01, 1995	Substantially Equivalent	Gamp & Assoc.
K952584	GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK	Sep 01, 1995	Substantially Equivalent	Gamp & Assoc.
K952580	GAMP & ASSOCIATES DISPOSABLE BARE END FIBER	Sep 01, 1995	Substantially Equivalent	Gamp & Assoc.