FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
K Number: K080300
·
Decision Apr 8, 2008
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
18
Applicant Total
31
Review Days
63
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Basic Information
- Device Name
- CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
- K Number
- K080300
- 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
- February 5, 2008
- Decision Date
- April 8, 2008
- Product Code
- NUV
- 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 |
|---|---|---|---|
| NUV | Massager, Vacuum, Light Induced Heating | FDA class 2 | General, Plastic Surgery |
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