ZEPTO Precision Capsulotomy System
FDA 510(k) clearance K210827 · decided 2021-12-14
Clearance details
- K-number
- K210827
- Device name
- ZEPTO Precision Capsulotomy System
- Applicant
- Centricity Vision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-03-19
- Decision date
- 2021-12-14
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- PUL
- Device class
- 2
- Regulation number
- 886.4100
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ZeptoLink IOL Positioning System (K223763) | Centricity Vision, Inc. | 2023-04-11 |
| ZEPTO Precision Capsulotomy System (K221188) | Centricity Vision, Inc. | 2022-06-23 |
| Zepto (K170655) | Mynosys Cellular Devices, Inc. | 2017-06-02 |
Recalls involving this device
No recalls on record reference this clearance.