510(k) K083203 ยท GEX Powered Laser Surgical Instrument
HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM
| Applicant | Laseroptek Co., Ltd., Torrance CA, US |
| Decision | Substantially Equivalent, Apr 28, 2009 |
| Received | Oct 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083203
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.