510(k) K083253 ยท GEX Powered Laser Surgical Instrument
LOTUS II PULSED ER: YAG LASER SYSTEM
| Applicant | Laseroptek Co., Ltd., Torrance CA, US |
| Decision | Substantially Equivalent, May 15, 2009 |
| Received | Nov 4, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083253
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.