FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
EndyMed Contour Handpiece
K Number: K161199
·
Decision Aug 1, 2016
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
77
Applicant Total
8
Review Days
95
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EndyMed Contour Handpiece
- K Number
- K161199
- 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
- April 28, 2016
- Decision Date
- August 1, 2016
- Product Code
- PBX
- 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 |
|---|---|---|---|
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PBX), ordered by most recent decision date.
SPECCHIO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Apollo Quattro (APQ-10M)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NeoSculpt Plus
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OptiLUV Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WinForth (LM-E470KA)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Zionic Pro Max (Radiofrequency)
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 |
| DEN150005 | Newa Skin Therapy System | Dec 18, 2015 | Unknown |
| K130501 | INTENSIF | Mar 13, 2014 | Substantially Equivalent |
| K120513 | GLOW BY ENDYMED | May 8, 2012 | Substantially Equivalent |
| K101510 | FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR | Feb 17, 2011 | Substantially Equivalent |