K173660 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 March 27, 2018, 118 days after receiving the submission on November 29, 2017.
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 | K173660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2017 |
| Decision Date | March 27, 2018 |
| Days to Decision | 118 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. |