510(k) K262628 ยท GEX Powered Laser Surgical Instrument
Picosecond Laser treatment system (Z180)
| Applicant | Sanhe PERFECTLASER Technology Co., Ltd., Langfang, CN |
| Decision | Substantially Equivalent, Oct 20, 2026 |
| Received | Jul 29, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262628
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.