FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CoolSculpting Elite System
K Number: K233732
·
Decision Sep 12, 2024
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
13
Applicant Total
1
Review Days
296
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Basic Information
- Device Name
- CoolSculpting Elite System
- K Number
- K233732
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4340
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics
- Date Received
- November 21, 2023
- Decision Date
- September 12, 2024
- 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 |
Similar 510(k) Clearances
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