K163551 is an FDA 510(k) clearance for the LenSx Laser System. This device is classified as a Ophthalmic Femtosecond Laser (Class II - Special Controls, product code OOE).
Submitted by Alcon Laboratories, Inc. (Lake Forest, US). The FDA issued a Cleared decision on February 3, 2017, 46 days after receiving the submission on December 19, 2016.
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 | K163551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2016 |
| Decision Date | February 03, 2017 |
| Days to Decision | 46 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. |