K231011 is an FDA 510(k) clearance for the Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Meridian AG (Thun, CH). The FDA issued a Cleared decision on September 12, 2023, 155 days after receiving the submission on April 10, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K231011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2023 |
| Decision Date | September 12, 2023 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQF - Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |