510(k) K110228 ยท HQB Photocoagulator And Accessories
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
| Applicant | Nidek Incorporated, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 23, 2011 |
| Received | Jan 26, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110228
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 19, 2015 | Nidek Inc MC-500 Multicolor Laser Photocoagulator;
Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy Terminated |
HQF | None listed |
| Nov 17, 2014 | Nidek Inc MC-500 Multicolor Laser Photocoagulator using software version 2.20.
Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases. Terminated |
HQF | None listed |
| Nov 17, 2014 | Nidek Inc Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20.
Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation fo Terminated |
HQF | None listed |
| Jul 30, 2014 | Nidek Inc MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures. Terminated |
HQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.