Product code HQE

Device name: Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Medical specialty: Ophthalmic
Device class: 2
Regulation number: 886.4150
Review panel: OP
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K212763	UniVit HE, UniVit UHS	Visioncare Devices, LLC	2022-08-10
K170183	Cetus system, Cetus probe	A.R.C Laser GmbH	2017-09-27
K153168	Bi-Blade Vitrectomy Cutter	Medical Instrument Development Laboratories	2016-04-29
K141065	CONSTELLATION VISION SYSTEM	Alcon Research, Ltd.	2014-08-22
K121675	VERSAVIT	Synergetics, Inc.	2012-06-21
K120170	PROCARE PLUS VITRECTOMY SYSTEM	Visioncare Devices, Inc.	2012-05-30
K102222	ULTIMATE VIT ENHAMCER (UVE)	Medical Instrument Development Laboratories, Inc.	2011-04-08
K033390	COLIBRI DISPOSABLE VITRECTOMY CUTTER	Microworld Medical Instruments, Inc.	2003-11-04
K030948	VMATE MODEL VMM1000	Howard Instruments, Inc.	2003-06-17
K023939	VELOCITY ADVANTAGE	Visioncare Devices, Inc.	2003-04-17
K020911	MID LABS AUTONOMOUS VIT ENHANCER (AVE)	Medical Instrument Development Laboratories, Inc.	2002-04-29
K010082	D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM	Dutch Ophthalmic USA, Inc.	2001-03-12
K992943	VIT ENHANCER	Medical Instrument Development Laboratories, Inc.	1999-12-10
K990292	I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN	Ophthalmic Consultants, Inc.	1999-11-19
K983797	D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM	Dutch Ophthalmic USA, Inc.	1999-03-03
K980399	PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20	Peregrine Surgical , Ltd.	1998-04-30
K980400	PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10	Peregrine Surgical , Ltd.	1998-04-30
K980488	STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM	Storz Instrument Co.	1998-03-23
K970670	REUSABLE VITRECTOMY PROBE	Altex Vision	1997-05-06
K970673	DISPOSABLE VITRECTOMY PROBE	Altex Vision	1997-05-05
K964743	STORZ E8010 ERGOTEC/PREMIERE ADAPTOR	Storz Instrument Co.	1997-02-03
K961738	VIT COMMANDER SYSTEM	Scieran Technologies, Inc.	1996-11-25
K960061	STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE	Storz Instrument Co.	1996-09-18
K961078	AUTOMATED VITRECTOMY DEVICE	Promex, Inc.	1996-06-14
K954816	STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX	Storz Instrument Co.	1996-03-04
K953575	STORZ MVS-3201 VITRECTOMY PROBE PACK	Storz Instrument Co.	1995-09-14
K953576	STORZ DP4505 VITREOUS MEMBRANE DISSECTOR	Storz Instrument Co.	1995-09-14
K950852	CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP)	H.S. Intl. Co., Inc.	1995-05-19
K950799	PRO-VIT	M. Imonti and Associates Inc.,	1995-04-28
K946135	INFINITECH ASPIRATING LASER PROBE	Surgical Technologies, Inc.	1995-04-18

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00812480011137	Bi-Blade®	MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.	2026-09-27
00812480011151	Bi-Blade®	MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.	2026-09-27
00812480011168	Bi-Blade®	MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.	2026-09-27
00812480011175	Bi-Blade®	MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.	2026-09-27
00812480011182	Bi-Blade®	MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.	2026-09-27
00812480013049	NA	MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.	2026-09-27
00812480011090	Bi-Blade®	MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.	2026-09-26
00812480011144	Bi-Blade®	MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.	2026-09-26
00812480011083	Bi-Blade®	MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.	2026-09-26
08717872002910	EVA, combined machine including Laser (SMA connector)	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2017-11-02
07612717071124	Alcon Grieshaber	Alcon Laboratories, Inc.	2016-09-24
07612717071100	Alcon Grieshaber	Alcon Laboratories, Inc.	2016-09-24
08717872019543	Disposable EVA Irrigation and Aspiration Tubing	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872019468	Disposable EVA Gravity Input Set	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872019451	Disposable EVA Accessory Set	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872019185	EVA Dust Cover. Accessory to EVA.	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872019178	EVA Cartridge with 0.5 L Collection Bag	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872019154	Disposable EVA Collection Bag 0.5 L	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872019130	Disposable EVA Drapes	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872019116	Disposable EVA VGPC Input Set	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872019109	Disposable High Speed Cutter 20G/8000CPM	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872019093	Disposable High Speed Cutter 23G/8000CPM	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872019086	Disposable High Speed Cutter 25G/8000CPM	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872019079	Disposable High Speed Cutter 27G/8000CPM	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872019055	EVA Vitrectomy Pack VGPC Input 27G	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872019048	EVA Vitrectomy Pack Gravity Input 27G	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872019024	EVA Vitrectomy Pack VGPC Input 25G	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872019017	EVA Vitrectomy Pack Gravity Input 25G	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872018997	EVA Vitrectomy Pack Gravity Input 23G	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23
08717872018980	EVA Vitrectomy Pack VGPC Input 20G	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2016-09-23

Product code HQE

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