PUL · Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
Ophthalmic · 21 CFR 886.4100 · Class 2
Overview
| Product Code | PUL |
|---|---|
| Device Name | Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered |
| Regulation | 21 CFR 886.4100 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.
Classification Rationale
Class II.
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K223763 | ZeptoLink IOL Positioning System | Centricity Vision, Inc. | Apr 11, 2023 | SESE |
| K221188 | ZEPTO Precision Capsulotomy System | Centricity Vision, Inc. | Jun 23, 2022 | SESE |
| K210827 | ZEPTO Precision Capsulotomy System | Centricity Vision, Inc. | Dec 14, 2021 | SESE |
| K170655 | Zepto | Mynosys Cellular Devices, Inc. | Jun 2, 2017 | SESE |
Top Applicants
- Centricity Vision, Inc. — 3 clearances
- Mynosys Cellular Devices, Inc. — 1 clearance
