510(k) K032085 ยท GEX Powered Laser Surgical Instrument
GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
| Applicant | Nidek, Inc., Lake Forest CA, US |
| Decision | Substantially Equivalent, Oct 3, 2003 |
| Received | Jul 7, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032085
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2015 | Nidek Inc Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system
GYC4DD-1:
The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including re Terminated |
GEX | None listed |
| Jul 14, 2015 | Nidek Inc Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System;
GYC4EP-01 0W02 and GYC4EP-1 0Z20;
The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in oph Terminated |
GEX | None listed |
| Aug 13, 2014 | Nidek Inc GYC-1000 Green Laser Photocoagulator system
The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulatio Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.