510(k) K101152 ยท GEX Powered Laser Surgical Instrument
NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810
| Applicant | Focus Medical, LLC, Bethel CT, US |
| Decision | Substantially Equivalent, Aug 18, 2010 |
| Received | Apr 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101152
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.