FDA 510(k) Applications Submitted by NIDEK, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K050336 |
02/10/2005 |
OPD-STATION SOFTWARE |
NIDEK, INC. |
| K020876 |
03/18/2002 |
ECHOSCAN, MODEL US-1800 |
NIDEK, INC. |
| K031733 |
06/04/2003 |
NON-CONTACT TONOMETER, MODEL NT-4000 |
NIDEK, INC. |
| K032085 |
07/07/2003 |
GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 |
NIDEK, INC. |
| K042785 |
10/06/2004 |
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 |
NIDEK, INC. |
| K013694 |
11/07/2001 |
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) |
NIDEK, INC. |
| K013760 |
11/13/2001 |
DC-3300 LASER DIODE PHOTOCOAGULATOR |
NIDEK, INC. |
| K013864 |
11/21/2001 |
MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 |
NIDEK, INC. |
| K014274 |
12/27/2001 |
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 |
NIDEK, INC. |
| K990119 |
01/13/1999 |
EPI-STAR SURGICAL LASER SYSTER |
NIDEK, INC. |
| K990900 |
03/18/1999 |
MICROKERATOME, MODEL MK-2000 |
NIDEK, INC. |
| K991284 |
04/15/1999 |
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM |
NIDEK, INC. |
| K970017 |
01/02/1997 |
NIDEK CYBERSCAN |
NIDEK, INC. |
| K980201 |
01/20/1998 |
DIO-LIGHT LASER SYSTEM |
NIDEK, INC. |
| K960287 |
01/22/1996 |
HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM |
NIDEK, INC. |
| K980475 |
02/06/1998 |
UNIPULSE CO2 SURGICAL LASER SYSTEM |
NIDEK, INC. |
| K980547 |
02/12/1998 |
NIDEK PRIMA MODEL GYC-1500/2000 |
NIDEK, INC. |
| K981447 |
04/22/1998 |
DIO-LIGHT 60 LASER SYSTEM |
NIDEK, INC. |
| K982295 |
07/01/1998 |
NIDEK LIGHTSCAN |
NIDEK, INC. |
| K973218 |
08/27/1997 |
NIDEK HANDY |
NIDEK, INC. |
| K973533 |
09/18/1997 |
NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF) |
NIDEK, INC. |
| K973828 |
10/07/1997 |
PRIMA KTP LASER SYSTEM |
NIDEK, INC. |
| K964353 |
11/01/1996 |
CYBERLASE CO2 LASER SYSTEM |
NIDEK, INC. |
| K974732 |
12/18/1997 |
NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000 |
NIDEK, INC. |
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