FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PicoSure Workstation
K Number: K173199
·
Decision Feb 7, 2018
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
7
Review Days
128
Basic Information
- Device Name
- PicoSure Workstation
- K Number
- K173199
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cynosure, Inc
- Date Received
- October 2, 2017
- Decision Date
- February 7, 2018
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Cynosure, Inc
| K Number | Device Name | ||
|---|---|---|---|
| K190678 | TempSure | Jul 24, 2019 | Substantially Equivalent |
| K182365 | TempSure System | Oct 24, 2018 | Substantially Equivalent |
| K171992 | SculpSure | Sep 26, 2017 | Substantially Equivalent |
| K171262 | TempSure | Sep 22, 2017 | Substantially Equivalent |
| K171111 | Sculpsure | Jun 13, 2017 | Substantially Equivalent |
| K160480 | PicoSure Workstation | May 17, 2016 | Substantially Equivalent |