510(k) K212707
K212707 is an FDA 510(k) premarket notification submitted by Zeltiq Aesthetics, Inc. for the device "CoolSculpting Elite System". The FDA issued a decision of Substantially Equivalent on November 5, 2021. The device falls under product code OOK (Dermal Cooling Pack/Vacuum/Massager), a Class II device regulated under 21 CFR 878.4340. Zeltiq Aesthetics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 2021
- Date Received
- August 26, 2021
- Clearance Type
- Special
- 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.