K223763 is an FDA 510(k) clearance for the ZeptoLink IOL Positioning System. This device is classified as a Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered (Class II - Special Controls, product code PUL).
Submitted by Centricity Vision, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 11, 2023, 117 days after receiving the submission on December 15, 2022.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4100. Used To Perform Anterior Capsulotomy During Cataract Surgery.
| 510(k) Number | K223763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2022 |
| Decision Date | April 11, 2023 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | PUL - Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4100 |
| Definition | Used To Perform Anterior Capsulotomy During Cataract Surgery |