FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TempSure
K Number: K190678
·
Decision Jul 24, 2019
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
98
Review Days
128
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Basic Information
- Device Name
- TempSure
- K Number
- K190678
- 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, Inc.
- Date Received
- March 18, 2019
- Decision Date
- July 24, 2019
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Cynosure, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K182365 | TempSure System | Oct 24, 2018 | Substantially Equivalent |
| K173199 | PicoSure Workstation | Feb 7, 2018 | Substantially Equivalent |
| K171992 | SculpSure | Sep 26, 2017 | Substantially Equivalent |
| K171262 | TempSure | Sep 22, 2017 | Substantially Equivalent |
| K171111 | Sculpsure | Jun 13, 2017 | Substantially Equivalent |
| K160470 | SculpSure | Jul 21, 2016 | Substantially Equivalent |
| K160480 | PicoSure Workstation | May 17, 2016 | Substantially Equivalent |
| K150724 | SculpSure | Jul 1, 2015 | Substantially Equivalent |
| K150230 | SculpSure | May 15, 2015 | Substantially Equivalent |
| K143105 | Picosure Workstation | Feb 23, 2015 | Substantially Equivalent |