FDA 510(k) Applications for Medical Device Product Code "HQE"
(Instrument, Vitreous Aspiration And Cutting, Ac-Powered)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K170183 | A.R.C. Laser GmbH | Cetus system, Cetus probe | 09/27/2017 |
| K141065 | ALCON RESEARCH, LTD. | CONSTELLATION VISION SYSTEM | 08/22/2014 |
| K970673 | ALTEX VISION | DISPOSABLE VITRECTOMY PROBE | 05/05/1997 |
| K970670 | ALTEX VISION | REUSABLE VITRECTOMY PROBE | 05/06/1997 |
| K010082 | DUTCH OPHTHALMIC USA, INC. | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM | 03/12/2001 |
| K983797 | DUTCH OPHTHALMIC USA, INC. | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM | 03/03/1999 |
| K030948 | HOWARD INSTRUMENTS, INC. | VMATE MODEL VMM1000 | 06/17/2003 |
| K153168 | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES | Bi-Blade Vitrectomy Cutter | 04/29/2016 |
| K020911 | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | MID LABS AUTONOMOUS VIT ENHANCER (AVE) | 04/29/2002 |
| K102222 | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | ULTIMATE VIT ENHAMCER (UVE) | 04/08/2011 |
| K992943 | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | VIT ENHANCER | 12/10/1999 |
| K033390 | MICROWORLD MEDICAL INSTRUMENTS, INC. | COLIBRI DISPOSABLE VITRECTOMY CUTTER | 11/04/2003 |
| K990292 | OPHTHALMIC CONSULTANTS, INC. | I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN | 11/19/1999 |
| K980399 | PEREGRINE SURGICAL LTD. | PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20 | 04/30/1998 |
| K980400 | PEREGRINE SURGICAL LTD. | PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 | 04/30/1998 |
| K961078 | PROMEX, INC. | AUTOMATED VITRECTOMY DEVICE | 06/14/1996 |
| K961738 | SCIERAN TECHNOLOGIES, INC. | VIT COMMANDER SYSTEM | 11/25/1996 |
| K960061 | STORZ INSTRUMENT CO. | STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE | 09/18/1996 |
| K954816 | STORZ INSTRUMENT CO. | STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX | 03/04/1996 |
| K964743 | STORZ INSTRUMENT CO. | STORZ E8010 ERGOTEC/PREMIERE ADAPTOR | 02/03/1997 |
| K980488 | STORZ INSTRUMENT CO. | STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM | 03/23/1998 |
| K121675 | SYNERGETICS, INC | VERSAVIT | 06/21/2012 |
| K023939 | VISION CARE DEVICES, INC. | VELOCITY ADVANTAGE | 04/17/2003 |
| K120170 | VISIONCARE DEVICES, INC. | PROCARE PLUS VITRECTOMY SYSTEM | 05/30/2012 |
| K212763 | VisionCare Devices, LLC. | UniVit HE, UniVit UHS | 08/10/2022 |
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