K240615 is an FDA 510(k) clearance for the Leos Laser and Endoscopy System. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Beaver-Visitec International, Inc. (Waltham, US). The FDA issued a Cleared decision on April 3, 2025, 394 days after receiving the submission on March 5, 2024.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K240615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2024 |
| Decision Date | April 03, 2025 |
| Days to Decision | 394 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQF - Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |