FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ZELTIQ AESTHETICS DERMAL COOLING DEVICE
K Number: DEN090002
·
Decision Aug 24, 2010
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
13
Applicant Total
4
Review Days
315
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Basic Information
- Device Name
- ZELTIQ AESTHETICS DERMAL COOLING DEVICE
- K Number
- DEN090002
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 878.4340
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- Zeltiq Aesthetics
- Date Received
- October 13, 2009
- Decision Date
- August 24, 2010
- Product Code
- OOK
- 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 |
|---|---|---|---|
| OOK | Dermal Cooling Pack/Vacuum/Massager | FDA class 2 | General, Plastic Surgery |
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