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510(k) DEN090002

ZELTIQ AESTHETICS DERMAL COOLING DEVICE by Zeltiq Aesthetics — Product Code OOK

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
August 24, 2010
Date Received
October 13, 2009
Clearance Type
Post-NSE
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

  • 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)
  • 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)

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)
  • 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)