FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE
K Number: K080530
·
Decision Aug 15, 2008
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
19
Review Days
171
Basic Information
- Device Name
- MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE
- K Number
- K080530
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CUTERA, INC.
- Date Received
- February 26, 2008
- Decision Date
- August 15, 2008
- 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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| K103626 | CUTERA GENESISPLUS LASER SYSTEM | Apr 5, 2011 | Substantially Equivalent |