FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CUTERA QSWITCH LASER SYSTEM
K Number: K102954
·
Decision Jun 22, 2011
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
19
Review Days
260
Basic Information
- Device Name
- CUTERA QSWITCH LASER SYSTEM
- K Number
- K102954
- 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
- October 5, 2010
- Decision Date
- June 22, 2011
- 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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|---|---|---|---|
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| 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 |
| K103626 | CUTERA GENESISPLUS LASER SYSTEM | Apr 5, 2011 | Substantially Equivalent |
| K092195 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Oct 1, 2009 | Substantially Equivalent |