FDA 510(k) Applications Submitted by JUDY F GORDON
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120732 |
03/09/2012 |
LENSSX LASER SYSTEM |
ALCON LENSX, INC. |
| K091064 |
04/14/2009 |
NAVILAS LASER SYSTEM |
OD -OS GMBH |
| K091579 |
06/02/2009 |
FORESEE HOME |
NOTAL VISION LTD. |
| K101626 |
06/09/2010 |
LENSX LASER SYSTEM |
LENSX LASERS, INC. |
| K092647 |
08/27/2009 |
LENSX 550 LASER SYSTEM |
LENSX LASERS, INC. |
| K993190 |
09/23/1999 |
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) |
SURGICAL INSTRUMENT SYSTEMS (SIS), LTD |
| K082947 |
10/02/2008 |
LENSX 550 LASER SYSTEM |
LENSX LASERS, INC. |
| K063682 |
12/11/2006 |
INTRALASE FUSION LASER |
INTRALASE CORP. |
| K094052 |
12/31/2009 |
LENSX 550 LASER SYSTEM. MODEL 550 |
LENSX LASERS, INC. |
| K123120 |
10/03/2012 |
LENSX LASER SYSTEM |
ALCON LENSX, INC. |
| K960414 |
01/29/1996 |
SYNERGIST POWER PACK |
CHIRON VISION CORP. |
| K990452 |
02/12/1999 |
ORLIGHT 2000 SURGICAL LASER SYSTEM |
YBEAM TECHNOLOGIES, INC. |
| K970727 |
02/28/1997 |
MPORT FOLDABLE LENS PLACEMENT SYSTEM |
CHIRON VISION CORP. |
| K000727 |
03/06/2000 |
BUFFLIGHT CLT SURGICAL LASER SYSTEM |
Y-BEAM TECHNOLOGIES, INC. |
| K000911 |
03/21/2000 |
MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057 |
HYSTERX, INC. |
| K050716 |
03/21/2005 |
ISCIENCE SURGICAL VISCOINJECTOR |
ISCIENCE SURGICAL CORPORATION |
| K990996 |
03/25/1999 |
GENYX MEDICAL INJECTION NEEDLE |
GENYX MEDICAL, INC. |
| K030957 |
03/27/2003 |
PERFECT CAPSULE |
MILVELLA PTY. LTD. |
| K991124 |
04/02/1999 |
VISIJET HYDROKERATOME, MODEL 50 |
VISIJET, INC. |
| K001146 |
04/10/2000 |
GENYX FLEXIBLE INJECTION NEEEDLE |
GENY MEDICAL, INC. |
| K041108 |
04/28/2004 |
ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA |
ISCIENCE SURGICAL CORPORATION |
| K051304 |
05/19/2005 |
ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM |
SCIENCE SURGICAL CORPORATION |
| K011840 |
06/12/2001 |
CERVILENZ UTERINE MEASURING SOUND |
CERVILENZ INC |
| K081744 |
06/19/2008 |
PASCAL SYNTHESIS DELIVERY SYSTEM |
OPTIMEDICA CORPORATION |
| K141851 |
07/09/2014 |
NAVILAS LASER SYSTEM |
OD -OS GMBH |
| K972808 |
07/28/1997 |
HANSATOME MICROKERATOME |
CHIRON VISION CORP. |
| K062336 |
08/10/2006 |
OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE |
OPTIMEDICA CORPORATION |
| K992714 |
08/12/1999 |
MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010 |
HYSTERX, INC. |
| K993695 |
11/02/1999 |
LIGA-LOOP SUTURE APPLICATOR |
HYSTERX, INC. |
| K023902 |
11/22/2002 |
SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE |
USGI MEDICAL, INC. |
| K053298 |
11/25/2005 |
ALPHASPHERE ORBITAL IMPLANT |
HYDRON PTY LIMITED |
| K132494 |
08/09/2013 |
VISCOELASTIC INJECTOR |
SIGHT SCIENCES, INC. |
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