OUH · Skin Resurfacing Rf Applicator
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | OUH |
|---|---|
| Device Name | Skin Resurfacing Rf Applicator |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
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.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150409 | VIVACE Electrosurgical System | Sung Hwan E&B Co.,Ltd | Jan 15, 2016 | SESE |
| K142833 | INTRAGen | Jeisys Medical, Inc. | Jun 4, 2015 | SESE |
| K130501 | INTENSIF | Endymed Medical, Ltd. | Mar 13, 2014 | SESE |
| K120513 | GLOW BY ENDYMED | Endymed Medical, Ltd. | May 8, 2012 | SESE |
| K101510 | FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR | Endymed Medical, Ltd. | Feb 17, 2011 | SESE |
Top Applicants
- Endymed Medical, Ltd. — 3 clearances
- Sung Hwan E&B Co.,Ltd — 1 clearance
- Jeisys Medical, Inc. — 1 clearance
