510(k) K221789 ยท GEX Powered Laser Surgical Instrument
IRIS Pi Q switched Nd YAG laser
| Applicant | Bio-Med USA, Inc., Ramsey NJ, US |
| Decision | Substantially Equivalent, Aug 9, 2022 |
| Received | Jun 21, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221789
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.