← Back to catalogue

CoolSculpting Elite Control Unit

FDA UDIEUDAMED

Class II (US FDA UDI)

by Zeltiq Aesthetics, Inc.

Identity

Trade Name
CoolSculpting Elite Control Unit FDA UDI
Generic Name
Cryolipolysis body contouring system control unit FDA UDI
Device Name
CoolSculpting Elite Control Unit FDA UDI
Model / Reference
CS-S3-002-D-00 FDA UDI
Description
CoolSculpting Elite Control Unit FDA UDI

Identifiers

Primary DI / UDI-DI
00816417021619 FDA UDI
FDA Product Code
OOK FDA UDI
GMDN Term
Cryolipolysis body contouring system control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4340 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cryolipolysis body contouring system control unit

CoolSculpting Elite Control Unit by Zeltiq Aesthetics, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Cryolipolysis body contouring system control unit.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Zeltiq Aesthetics, Inc.

Sources (2)

  • FDA UDI b5e16267-0ad6-4402-a625-619b6cc5e7e6 33 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced May 29, 2026