FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
RF Thermal System
K Number: K210129
·
Decision Jul 20, 2021
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
77
Applicant Total
5
Review Days
182
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 Thermal System
- K Number
- K210129
- 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
- Luvo Medical Technologies, Inc.
- Date Received
- January 19, 2021
- Decision Date
- July 20, 2021
- 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