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 |