PUL
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4100
- Medical specialty
- Ophthalmic
- FDA definition
- Used to perform anterior capsulotomy during cataract surgery
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 Precision Capsulotomy System (K210827) | Centricity Vision, Inc. | 2021-12-14 |
| Zepto (K170655) | Mynosys Cellular Devices, Inc. | 2017-06-02 |
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