OUH — Skin Resurfacing Rf Applicator Class II
FDA product code OUH covers "Skin Resurfacing Rf Applicator", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OUH
- Device Class
- Class II
- Regulation Number
- 878.4400
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Skin resurfacing
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K150409 | sung hwan e and b co | VIVACE Electrosurgical System | January 15, 2016 |
| K142833 | jeisys medical | INTRAGen | June 4, 2015 |
| K130501 | endymed medical | INTENSIF | March 13, 2014 |
| K120513 | endymed medical | GLOW BY ENDYMED | May 8, 2012 |
| K101510 | endymed medical | FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR | February 17, 2011 |