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CoolSculpting Solo

FDA UDI

Class II (US FDA UDI)

by Zeltiq Aesthetics, Inc.

Identity

Trade Name
CoolSculpting Solo FDA UDI
Generic Name
Cryolipolysis body contouring system control unit FDA UDI
Device Name
CoolSculpting Solo Control Unit FDA UDI
Model / Reference
CS-S2-002-D-00 FDA UDI
Description
CoolSculpting Solo Control Unit FDA UDI

Identifiers

Primary DI / UDI-DI
00816417021459 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 Solo by Zeltiq Aesthetics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cryolipolysis body contouring system control unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zeltiq Aesthetics, Inc.

Sources (1)

  • FDA UDI cf327476-8f71-4686-9efb-205fbaba8913 34 fields · synced Jun 8, 2026