K122829 is an FDA 510(k) clearance for the LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Lensar, Inc. (Orlando, US). The FDA issued a Cleared decision on December 3, 2012, 77 days after receiving the submission on September 17, 2012.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K122829 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2012 |
| Decision Date | December 03, 2012 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQC - Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |