FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)
K Number: K101366
·
Decision Sep 17, 2010
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
18
Applicant Total
1
Review Days
123
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Basic Information
- Device Name
- I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)
- K Number
- K101366
- 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
- Chromogenex Technologies, Ltd.
- Date Received
- May 17, 2010
- Decision Date
- September 17, 2010
- 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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