510(k) K133358 ยท HQF Laser, Ophthalmic
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
| Applicant | Nidek Co., Ltd., Albignasego (Padova), IT |
| Decision | Substantially Equivalent, Aug 12, 2014 |
| Received | Oct 31, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133358
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.