510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171069Substantially Equivalent

ZELTIQ CoolSculpting System

Zeltiq Aesthetics Inc, Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171069 is the FDA 510(k) clearance record for ZELTIQ CoolSculpting System, a class II device, cleared for Zeltiq Aesthetics, Inc. on under FDA product code OOK (Dermal Cooling Pack/Vacuum/Massager). FDA's definition for product code OOK reads: "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". FDA records list 17 510(k) clearances for Zeltiq Aesthetics, Inc., from to . As of , FDA records show no recalls naming K171069.

Clearance record

Decision date
Received
(88 days to decision)
Product code
OOK Dermal Cooling Pack/Vacuum/Massager
Regulation
21 CFR 878.4340
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Zeltiq Aesthetics, Inc. 4410 Rosewood Rd., Pleasanton CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OOK

Trailing 12 months

FDA records hold no clearances under product code OOK in the trailing twelve months.

FDA records show no clearances under product code OOK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OOK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260