510(k) K212707

CoolSculpting Elite System by Zeltiq Aesthetics, Inc. — Product Code OOK

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.

Other clearances by Zeltiq Aesthetics, Inc.

K233804 — Resonic Rapid Acoustic Pulse Device (February 1, 2024)
K222629 — Resonic Rapid Acoustic Pulse Device (September 25, 2022)
K193566 — ZELTIQ CoolSculpting System (January 21, 2020)
K183514 — ZELTIQ CoolSculpting System (January 14, 2019)
K181740 — ZELTIQ CoolSculpting System (August 29, 2018)
K172144 — CoolSculpting System (November 1, 2017)
K171069 — ZELTIQ CoolSculpting System (July 7, 2017)
K162050 — ZELTIQ CoolSculpting System (November 21, 2016)
K160259 — ZELTIQ CoolSculpting System (March 23, 2016)
K151179 — ZELTIQ CoolSculpting System (September 22, 2015)

Other clearances for product code OOK

K233732 — CoolSculpting Elite System (September 12, 2024)
K193566 — ZELTIQ CoolSculpting System (January 21, 2020)
K183514 — ZELTIQ CoolSculpting System (January 14, 2019)
K181740 — ZELTIQ CoolSculpting System (August 29, 2018)
K172144 — CoolSculpting System (November 1, 2017)
K171069 — ZELTIQ CoolSculpting System (July 7, 2017)
K162050 — ZELTIQ CoolSculpting System (November 21, 2016)
K160259 — ZELTIQ CoolSculpting System (March 23, 2016)
K151179 — ZELTIQ CoolSculpting System (September 22, 2015)
K142491 — ZEL TIQ CoolSculpting System (January 26, 2015)