FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TempSure System
K Number: K200241
·
Decision Mar 25, 2020
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
77
Applicant Total
8
Review Days
54
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
- TempSure System
- K Number
- K200241
- 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
- Cynosure, LLC
- Date Received
- January 31, 2020
- Decision Date
- March 25, 2020
- 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 Cynosure, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K261570 | PICOSURE WORKSTATION | Jun 17, 2026 | Substantially Equivalent |
| K240396 | Elite iQ PRO (M122K1) | Mar 8, 2024 | Substantially Equivalent |
| K230510 | MyEllevate | Jul 6, 2023 | Substantially Equivalent |
| K223292 | TempSure System | Nov 23, 2022 | Substantially Equivalent |
| K212891 | TempSure System | Mar 18, 2022 | Substantially Equivalent |
| K210226 | PicoSure Workstation | Mar 30, 2021 | Substantially Equivalent |
| K193426 | Elite iQ | Mar 9, 2020 | Substantially Equivalent |