FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CUTERA ER:YAG LASER HANDPIECE
K Number: K070138
·
Decision Mar 27, 2007
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
19
Review Days
70
Basic Information
- Device Name
- CUTERA ER:YAG LASER HANDPIECE
- K Number
- K070138
- 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
- CUTERA, INC.
- Date Received
- January 16, 2007
- Decision Date
- March 27, 2007
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
AviClear Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pastelle
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SurgiLight 1470 Diode Laser System (Model:Halo)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AuroLase® System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Diode laser device (RF3120-BI)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by CUTERA, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K162512 | truSculpt | Dec 9, 2016 | Substantially Equivalent |
| K153671 | Family of CoolGlide Aesthetic Lasers | Mar 9, 2016 | Substantially Equivalent |
| K140727 | CUTERA PICOSECOND LASER SYSTEM | Nov 6, 2014 | Substantially Equivalent |
| K133739 | TRUSCULPT | Sep 5, 2014 | Substantially Equivalent |
| K133945 | CUTERA PICOSECOND LASER SYSTEM | Aug 11, 2014 | Substantially Equivalent |
| K132185 | FAMILY OF COOLGLIDE AESTHETIC LASERS | Dec 6, 2013 | Substantially Equivalent |
| K122493 | GENESISPLUS | May 15, 2013 | Substantially Equivalent |
| K122389 | TRUSCULPT | Nov 2, 2012 | Substantially Equivalent |
| K102954 | CUTERA QSWITCH LASER SYSTEM | Jun 22, 2011 | Substantially Equivalent |
| K103626 | CUTERA GENESISPLUS LASER SYSTEM | Apr 5, 2011 | Substantially Equivalent |