Glow by Endymed
FDA 510(k) K120513 · Endymed Medical, Ltd.
510(k) numberK120513
Submission
- Device name
- Glow by Endymed
- Applicant
- Endymed Medical, Ltd.
Binyamina, IL - Received
- February 21, 2012
- Decision date
- May 8, 2012
- 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 |
| K101510 | Fractional Skin Resurfacing (FSR) ApplicatorOUH · Traditional | Endymed Medical, Ltd. | 02/17/2011SE |
More from Endymed Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K101510 | Fractional Skin Resurfacing (FSR) ApplicatorOUH · Traditional | 02/17/2011SE |
Questions and answers
When was Glow by Endymed cleared by the FDA?
Glow by Endymed (K120513) received a 510(k) decision of Substantially Equivalent on May 8, 2012, 77 days after the submission was received.
What is the product code of K120513?
The FDA product code is OUH – Skin Resurfacing Rf Applicator, a Class II (moderate risk) device regulated under 21 CFR 878.4400.