FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
RF-Relief
K Number: K181095
·
Decision Jul 24, 2018
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
77
Applicant Total
12
Review Days
89
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
- RF-Relief
- K Number
- K181095
- 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
- El Global Trade, Ltd.
- Date Received
- April 26, 2018
- Decision Date
- July 24, 2018
- 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 El Global Trade, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252621 | DeepSkin (DEP100) | May 8, 2026 | Substantially Equivalent |
| K250341 | Sensilift Pro (ST300XXYYZZZ) | Jan 6, 2026 | Substantially Equivalent |
| K250384 | IPL400 | May 23, 2025 | Substantially Equivalent |
| K232424 | CurrentBody Skin RF | Mar 6, 2024 | Substantially Equivalent |
| K183260 | Sensilight Pro / Pistol IPL | Mar 18, 2019 | Substantially Equivalent |
| K172181 | micro IPL | Oct 13, 2017 | Substantially Equivalent |
| K170637 | sensiFirm | Jul 14, 2017 | Substantially Equivalent |
| K170499 | sensiLift | Jun 15, 2017 | Substantially Equivalent |
| K161089 | sensiLight Mini | Jul 8, 2016 | Substantially Equivalent |
| K140381 | SENSILIGHT/ SENSILIGHT PLUS | Aug 8, 2014 | Substantially Equivalent |