510(k) K252561 ยท GEX Powered Laser Surgical Instrument
BTL-754FF
| Applicant | BTL Industries, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Feb 18, 2026 |
| Received | Aug 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252561
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.