510(k) K262701 ยท GEX Powered Laser Surgical Instrument
PicoPeak Picosecond Nd:Yag Laser System (Bella-9)
| Applicant | Beijing Sea Heart International Science and Technologyco.Ltd, Beijing, CN |
| Decision | Substantially Equivalent, Oct 22, 2026 |
| Received | Jul 31, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262701
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.