Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4100](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4100) → PUL — Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

# PUL · Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

_Ophthalmic · 21 CFR 886.4100 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/PUL

## Overview

- **Product Code:** PUL
- **Device Name:** Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
- **Regulation:** [21 CFR 886.4100](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4100)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## 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.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K223763](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/PUL/K223763.md) | ZeptoLink IOL Positioning System | Centricity Vision, Inc. | Apr 11, 2023 | SESE |
| [K221188](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/PUL/K221188.md) | ZEPTO Precision Capsulotomy System | Centricity Vision, Inc. | Jun 23, 2022 | SESE |
| [K210827](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/PUL/K210827.md) | ZEPTO Precision Capsulotomy System | Centricity Vision, Inc. | Dec 14, 2021 | SESE |
| [K170655](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/PUL/K170655.md) | Zepto | Mynosys Cellular Devices, Inc. | Jun 2, 2017 | SESE |

## Top Applicants

- Centricity Vision, Inc. — 3 clearances
- Mynosys Cellular Devices, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/PUL](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/PUL)

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