K210827 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 December 14, 2021, 270 days after receiving the submission on March 19, 2021.
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 | K210827 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2021 |
| Decision Date | December 14, 2021 |
| Days to Decision | 270 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 |