510(k) K261214 ยท GEX Powered Laser Surgical Instrument
PICO SHINING (PICO-K; PICOFY)
| Applicant | Speclipse, Inc., Gyeonggi-Do, KR |
| Decision | Substantially Equivalent, May 11, 2026 |
| Received | Apr 14, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261214
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.