FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER
K Number: K031440
·
Decision Oct 1, 2003
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
91
Review Days
148
Basic Information
- Device Name
- SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER
- K Number
- K031440
- 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
- May 6, 2003
- Decision Date
- October 1, 2003
- 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 | ||
|---|---|---|---|
| K160470 | SculpSure | Jul 21, 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 |
| K141511 | SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS | Jan 23, 2015 | Substantially Equivalent |
| K142376 | Palomar Icon Aesthetic System | Sep 24, 2014 | Substantially Equivalent |
| K140719 | PICOSURE WORKSTATION | Sep 22, 2014 | Substantially Equivalent |
| K141425 | ELITE + LASER SYSTEM | Sep 11, 2014 | Substantially Equivalent |
| K133364 | PICOSURE WORKSTATION | Jul 22, 2014 | Substantially Equivalent |
| K133254 | REVLITE Q-SWITCHED ND:YAG LASER SYSTEM | Mar 5, 2014 | Substantially Equivalent |