K213559 is an FDA 510(k) clearance for the FEMTO LDV Z8 Femtosecond Surgical Laser. This device is classified as a Ophthalmic Femtosecond Laser (Class II - Special Controls, product code OOE).
Submitted by Sie Ag,Surgical Instrument Engineering (Port, CH). The FDA issued a Cleared decision on April 21, 2022, 168 days after receiving the submission on November 4, 2021.
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 | K213559 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2021 |
| Decision Date | April 21, 2022 |
| Days to Decision | 168 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. |