K221188 is an FDA 510(k) clearance for the ZEPTO Precision Capsulotomy 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 June 23, 2022, 59 days after receiving the submission on April 25, 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 | K221188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2022 |
| Decision Date | June 23, 2022 |
| Days to Decision | 59 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 |