Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400) → OUH — Skin Resurfacing Rf Applicator

# OUH · Skin Resurfacing Rf Applicator

_General, Plastic Surgery · 21 CFR 878.4400 · Class 2_

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

## Overview

- **Product Code:** OUH
- **Device Name:** Skin Resurfacing Rf Applicator
- **Regulation:** [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

## Classification Rationale

Class II.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K150409](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OUH/K150409.md) | VIVACE Electrosurgical System | Sung Hwan E&B Co.,Ltd | Jan 15, 2016 | SESE |
| [K142833](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OUH/K142833.md) | INTRAGen | Jeisys Medical, Inc. | Jun 4, 2015 | SESE |
| [K130501](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OUH/K130501.md) | INTENSIF | Endymed Medical, Ltd. | Mar 13, 2014 | SESE |
| [K120513](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OUH/K120513.md) | GLOW BY ENDYMED | Endymed Medical, Ltd. | May 8, 2012 | SESE |
| [K101510](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OUH/K101510.md) | FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR | Endymed Medical, Ltd. | Feb 17, 2011 | SESE |

## Top Applicants

- Endymed Medical, Ltd. — 3 clearances
- Jeisys Medical, Inc. — 1 clearance
- Sung Hwan E&B Co.,Ltd — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com