510(k) K240615 ยท HQF Laser, Ophthalmic
Leos Laser and Endoscopy System
| Applicant | Beaver-Visitec International, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Apr 3, 2025 |
| Received | Mar 5, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240615
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2025 | Beaver-Visitec International, Inc. BVI Leos Laser and Endoscopy System. Model Number: OME6000U. Open, Classified |
HQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.