510(k) K161632 ยท GEX Powered Laser Surgical Instrument
FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)
| Applicant | Bios S.R.L., Vimodrone, IT |
| Decision | Substantially Equivalent, Dec 8, 2016 |
| Received | Jun 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161632
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.