K151161 is an FDA 510(k) clearance for the VICTUS Femtosecond Laser Platform. This device is classified as a Ophthalmic Femtosecond Laser (Class II - Special Controls, product code OOE).
Submitted by Technolas Perfect Vision GmbH (München, DE). The FDA issued a Cleared decision on June 24, 2015, 54 days after receiving the submission on May 1, 2015.
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 | K151161 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2015 |
| Decision Date | June 24, 2015 |
| Days to Decision | 54 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. |