K120426 is an FDA 510(k) clearance for the VICTUS LASER PLATFORM. This device is classified as a Ophthalmic Femtosecond Laser (Class II - Special Controls, product code OOE).
Submitted by Technolas Perfect Vision GmbH (San Francisco, US). The FDA issued a Cleared decision on July 31, 2012, 169 days after receiving the submission on February 13, 2012.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390. Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery..
| 510(k) Number | K120426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2012 |
| Decision Date | July 31, 2012 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | OOE - Ophthalmic Femtosecond Laser |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |
| Definition | Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery. |