FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
GLOW BY ENDYMED
K Number: K120513
·
Decision May 8, 2012
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
4
Applicant Total
8
Review Days
77
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Basic Information
- Device Name
- GLOW BY ENDYMED
- K Number
- K120513
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endymed Medical, Ltd.
- Date Received
- February 21, 2012
- Decision Date
- May 8, 2012
- Product Code
- OUH
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OUH | Skin Resurfacing Rf Applicator | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OUH), ordered by most recent decision date.
VIVACE Electrosurgical System
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INTENSIF
FDA 510(k)
FDA Class 2
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FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Endymed Medical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242996 | EndyMed PRO MAX | Jun 10, 2025 | Substantially Equivalent |
| K222369 | PURE Laser | Oct 7, 2022 | Substantially Equivalent |
| K161715 | EndyGel | Feb 7, 2017 | Substantially Equivalent |
| K161199 | EndyMed Contour Handpiece | Aug 1, 2016 | Substantially Equivalent |
| DEN150005 | Newa Skin Therapy System | Dec 18, 2015 | Unknown |
| K130501 | INTENSIF | Mar 13, 2014 | Substantially Equivalent |
| K101510 | FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR | Feb 17, 2011 | Substantially Equivalent |