PUL — Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered Class II
FDA product code PUL covers "Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered", a Class II medical device regulated under 21 CFR 886.4100. Submissions are reviewed by the Ophthalmic panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PUL
- Device Class
- Class II
- Regulation Number
- 886.4100
- Submission Type
- 510(k)
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
Used to perform anterior capsulotomy during cataract surgery
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K223763 | Centricity Vision | ZeptoLink IOL Positioning System | Apr 11, 2023 |
| K221188 | Centricity Vision | ZEPTO Precision Capsulotomy System | Jun 23, 2022 |
| K210827 | Centricity Vision | ZEPTO Precision Capsulotomy System | Dec 14, 2021 |
| K170655 | Mynosys Cellular Devices | Zepto | Jun 2, 2017 |