510(k) K230342 ยท GEX Powered Laser Surgical Instrument
Phototherapy System (OL-PDT950)
| Applicant | Shanghai Omni Laser Skinology Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Aug 16, 2023 |
| Received | Feb 8, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230342
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.