Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K032085 |
Device Name |
GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 |
Applicant |
NIDEK, INC. |
21911 ERIE LN. |
LAKE FOREST,
CA
92630
|
|
Applicant Contact |
CAROL PATTERSON |
Correspondent |
NIDEK, INC. |
21911 ERIE LN. |
LAKE FOREST,
CA
92630
|
|
Correspondent Contact |
CAROL PATTERSON |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 07/07/2003 |
Decision Date | 10/03/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|