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510(k) K183514

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2019
Date Received
December 18, 2018
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)
  • K212707 — CoolSculpting Elite System (November 5, 2021)
  • K193566 — ZELTIQ CoolSculpting System (January 21, 2020)
  • 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)
  • K212707 — CoolSculpting Elite System (November 5, 2021)
  • K193566 — ZELTIQ CoolSculpting System (January 21, 2020)
  • 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)