ZELTIQ AESTHETICS, INC.

FDA Device Registration & Listing · Pleasanton, CA, US · Registration 3007215625

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007215625
FEI Number
3007215625
Entity Name
ZELTIQ AESTHETICS, INC.
City/State/Country
Pleasanton, CA, US
Establishment Address
4410 Rosewood Dr, Pleasanton, CA 94588, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ZELTIQ Aesthetics, Inc. (Owner Number: 10025698)
Owner / Operator Contact Address
4410 Rosewood Drive, Pleasanton, CA 94588, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K160259
PMA Number
N/A

All Registered Proprietary Names

CoolSculpting System CoolSculpting System ZELTIQ Breeze System CoolSculpting System SilkPeel Spa DPRO EnDoucer Dermolissage SilkPeel MD SilkPeel Pro SP3 Silk Peel Dermalinfusion CoolSculpting Elite System CoolSculpting System CoolSculpting Elite System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2015-04-27
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2020-03-06
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2015-12-02
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2013-01-14
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2018-02-05
GFE Brush, Dermabrasion, Powered General, Plastic Surgery Class 1 878.4820 2020-01-16
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2021-11-09
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2014-04-25
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2025-12-19
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2016-04-05

Official Correspondent

Difei Chai

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ZELTIQ Aesthetics, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3011837770 ZELTIQ AESTHETICS, INC. Livermore, CA, US
3014214244 Zeltiq Aesthetics Inc Dublin, CA, US
3009974688 ZELTIQ AESTHETICS INC. Dublin, CA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007215625. Last updated year: 2026. Please use registration number 3007215625 when referencing this establishment in official correspondence.
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