510(k) K071469 ยท GEX Powered Laser Surgical Instrument
INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM
| Applicant | Candela Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Aug 15, 2007 |
| Received | May 29, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071469
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.