510(k) K233732
K233732 is an FDA 510(k) premarket notification submitted by Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics for the device "CoolSculpting Elite System". The FDA issued a decision of Substantially Equivalent on September 12, 2024. The device falls under product code OOK (Dermal Cooling Pack/Vacuum/Massager), a Class II device regulated under 21 CFR 878.4340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2024
- Date Received
- November 21, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dermal Cooling Pack/Vacuum/Massager
- Device Class
- Class II
- Regulation Number
- 878.4340
- Review Panel
- SU
- Submission Type
The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption or induction of adipocyte cells indicated for body contouring or reduction in circumference of body areas.