K072823 is an FDA 510(k) clearance for the MERILAS 532A. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Meridian AG (Littleton, US). The FDA issued a Cleared decision on December 14, 2007, 73 days after receiving the submission on October 2, 2007.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K072823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2007 |
| Decision Date | December 14, 2007 |
| Days to Decision | 73 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 |