FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZELTIQ COOLSCULPTING SYSTEM
K Number: K133212
·
Decision Apr 9, 2014
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
13
Applicant Total
5
Review Days
173
Basic Information
- Device Name
- ZELTIQ COOLSCULPTING SYSTEM
- K Number
- K133212
- 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.
- Date Received
- October 18, 2013
- Decision Date
- April 9, 2014
- 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
Other 510(k) clearances with the same product code (OOK), ordered by most recent decision date.
CoolSculpting Elite System
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Other Clearances by ZELTIQ AESTHETICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K160259 | ZELTIQ CoolSculpting System | Mar 23, 2016 | Substantially Equivalent |
| K151179 | ZELTIQ CoolSculpting System | Sep 22, 2015 | Substantially Equivalent |
| K142491 | ZEL TIQ CoolSculpting System | Jan 26, 2015 | Substantially Equivalent |
| K120023 | ZELTIQ COOLSCULPTING | May 2, 2012 | Substantially Equivalent |