510(k) K113018 ยท GEX Powered Laser Surgical Instrument
APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM
| Applicant | BEIJING SYNTECH LASER CO., LTD., Shanghai, CN |
| Decision | Substantially Equivalent, Dec 14, 2012 |
| Received | Oct 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113018
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.