510(k) K233007 ยท GEX Powered Laser Surgical Instrument
Picosecond Nd:YAG Laser System; PICO LEGEND
| Applicant | Ami, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Jun 12, 2024 |
| Received | Sep 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233007
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.