The following data is part of a premarket notification filed by Centricity Vision, Inc. with the FDA for Zepto Precision Capsulotomy System.
| Device ID | K221188 |
| 510k Number | K221188 |
| Device Name: | ZEPTO Precision Capsulotomy System |
| Classification | Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered |
| Applicant | Centricity Vision, Inc. 1939 Palomar Oaks Way, Suite A Carlsbad, CA 92011 |
| Contact | Neal Hartman |
| Correspondent | Neal Hartman Centricity Vision, Inc. 1939 Palomar Oaks Way, Suite A Carlsbad, CA 92011 |
| Product Code | PUL |
| CFR Regulation Number | 886.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-25 |
| Decision Date | 2022-06-23 |