Fractional Skin Resurfacing (FSR) Applicator
FDA 510(k) K101510 · Endymed Medical, Ltd.
510(k) numberK101510
Submission
- Device name
- Fractional Skin Resurfacing (FSR) Applicator
- Applicant
- Endymed Medical, Ltd.
Binyamina, IL - Received
- June 1, 2010
- Decision date
- February 17, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OUH – Skin Resurfacing Rf Applicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Skin resurfacing
Other 510(k)s with product code OUH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150409 | VIVACE Electrosurgical SystemOUH · Traditional | Sung Hwan E&B Co.,Ltd | 01/15/2016SE |
| K142833 | INTRAGenOUH · Traditional | Jeisys Medical, Inc. | 06/04/2015SE |
| K130501 | IntensifOUH · Traditional | Endymed Medical, Ltd. | 03/13/2014SE |
| K120513 | Glow by EndymedOUH · Traditional | Endymed Medical, Ltd. | 05/08/2012SE |
More from Endymed Medical, Ltd.
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|---|---|---|
| K242996 | EndyMed PRO MAXGEI · Traditional | 06/10/2025SE |
| K222369 | PURE LaserGEX · Traditional | 10/07/2022SE |
| K161715 | EndyGelGYB · Traditional | 02/07/2017SE |
| K161199 | EndyMed Contour HandpiecePBX · Traditional | 08/01/2016SE |
| K130501 | IntensifOUH · Traditional | 03/13/2014SE |
| K120513 | Glow by EndymedOUH · Traditional | 05/08/2012SE |
Questions and answers
When was Fractional Skin Resurfacing (FSR) Applicator cleared by the FDA?
Fractional Skin Resurfacing (FSR) Applicator (K101510) received a 510(k) decision of Substantially Equivalent on February 17, 2011, 261 days after the submission was received.
What is the product code of K101510?
The FDA product code is OUH – Skin Resurfacing Rf Applicator, a Class II (moderate risk) device regulated under 21 CFR 878.4400.