510(k) K151473 ยท GEX Powered Laser Surgical Instrument
NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module
| Applicant | Focus Medical, LLC, Bethel CT, US |
| Decision | Substantially Equivalent, Sep 1, 2015 |
| Received | Jun 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151473
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.