Skin Resurfacing Rf Applicator
The Skin Resurfacing RF Applicator (product code OUH) is a radiofrequency device used for skin resurfacing procedures, which involve the controlled application of RF energy to the skin to improve its texture, tone, and appearance. It is used in aesthetic and reconstructive plastic surgery settings. As an FDA Class 2 device under regulation 878.4400, it requires 510(k) premarket clearance and falls within the General and Plastic Surgery specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OUH
- Device Class
- FDA class 2
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
Skin resurfacing
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K150409 | VIVACE Electrosurgical System | Jan 15, 2016 | Substantially Equivalent | Sung Hwan E&B Co.,Ltd |
| K142833 | INTRAGen | Jun 04, 2015 | Substantially Equivalent | Jeisys Medical, Inc. |
| K130501 | INTENSIF | Mar 13, 2014 | Substantially Equivalent | Endymed Medical, Ltd. |
| K120513 | GLOW BY ENDYMED | May 08, 2012 | Substantially Equivalent | Endymed Medical, Ltd. |
| K101510 | FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR | Feb 17, 2011 | Substantially Equivalent | Endymed Medical, Ltd. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.