FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZELTIQ CoolSculpting System
K Number: K160259
·
Decision Mar 23, 2016
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
13
Applicant Total
13
Review Days
51
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Basic Information
- Device Name
- ZELTIQ CoolSculpting System
- K Number
- K160259
- 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
- February 1, 2016
- Decision Date
- March 23, 2016
- 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
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoolSculpting Elite System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZELTIQ CoolSculpting System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZELTIQ CoolSculpting System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZELTIQ CoolSculpting System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoolSculpting System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Zeltiq Aesthetics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233804 | Resonic Rapid Acoustic Pulse Device | Feb 1, 2024 | Substantially Equivalent |
| K222629 | Resonic Rapid Acoustic Pulse Device | Sep 25, 2022 | Substantially Equivalent |
| K212707 | CoolSculpting Elite System | Nov 5, 2021 | Substantially Equivalent |
| K193566 | ZELTIQ CoolSculpting System | Jan 21, 2020 | Substantially Equivalent |
| K183514 | ZELTIQ CoolSculpting System | Jan 14, 2019 | Substantially Equivalent |
| K181740 | ZELTIQ CoolSculpting System | Aug 29, 2018 | Substantially Equivalent |
| K171069 | ZELTIQ CoolSculpting System | Jul 7, 2017 | Substantially Equivalent |
| K162050 | ZELTIQ CoolSculpting System | Nov 21, 2016 | Substantially Equivalent |
| K151179 | ZELTIQ CoolSculpting System | Sep 22, 2015 | Substantially Equivalent |
| K142491 | ZEL TIQ CoolSculpting System | Jan 26, 2015 | Substantially Equivalent |