510(k) K253100 ยท GEX Powered Laser Surgical Instrument
MultiPulse TFL
| Applicant | Asclepion Laser Technologies GmbH, Jena, DE |
| Decision | Substantially Equivalent, Oct 23, 2025 |
| Received | Sep 24, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253100
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.