FDA.reportPublic FDA data

Cryolipolysis body contouring system

Definition
An assembly of devices designed to non-invasively apply cold to the skin and subcutaneous tissues for subcutaneous fat layer reduction through cold-assisted lipolysis (coolsculpting); it may additionally be used to provide local anaesthesia for procedures that produce minor discomfort. It primarily consists of a mains electricity (AC-powered) control unit to produce the thermal energy, and an applicator and gel pad to convey the thermal energy to the target area (e.g., chin, hips, abdomen, thighs); additional components may be included (e.g., disposable liner for the applicator, electronic program cards, pager).
GUDID devices
35
Last updated
2021-08-16 17:17:52

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00816417021329CoolSculpting Applicator Cable Support ArmZeltiq Aesthetics, Inc.BRZ-RP1-ARM-0012021-08-06
00816417021350CoolAdvantage Petite Comfort StrapZeltiq Aesthetics, Inc.BRZ-SS1-140-0022021-08-06
00816417022739CoolMini Support Arm SystemZeltiq Aesthetics, Inc.BRZ-RP2-ARM-0012021-08-06
00816417023064CoolMini Securement StrapsZeltiq Aesthetics, Inc.BRZ-SS7-02X-0022021-08-06
00816417021664CoolSculpting Securement System Straps-SmallZeltiq Aesthetics, Inc.CS-SS-SM-02-002021-04-30
00816417022630CoolSculpting Elite Securement Grip, S150Zeltiq Aesthetics, Inc.cs-ss-s15-02-002021-04-30
00816417021527CoolSculpting Quad Comfort StrapZeltiq Aesthetics, Inc.CS-SS-QD-02-002020-12-09
00816417022302Foam Borders, S150 ApplicatorZeltiq Aesthetics, Inc.CS-FB-15S-01-002020-12-09
00816417021510Gel Trap C80Zeltiq Aesthetics, Inc.CS-GT-08C-10-002020-08-31
00816417021534Gel Trap V3Zeltiq Aesthetics, Inc.CS-GT-V03-10-002020-08-31
00816417021626Pre-Treatment Skin WipeZeltiq Aesthetics, Inc.CS-CD-PSW-10-002020-08-31
00816417021633CoolSculpting Securement Strap Extra LargeZeltiq Aesthetics, Inc.CS-SS-XL-02-002020-08-31
00816417021640CoolSculpting Securement System Straps LargeZeltiq Aesthetics, Inc.CS-SS-LG-02-002020-08-31
00816417021657CoolSculpting Securement System Straps - MediumZeltiq Aesthetics, Inc.CS-SS-MD-02-002020-08-31
00816417021671CoolSculpting Securement Straps Extra SmallZeltiq Aesthetics, Inc.CS-SS-XS-02-002020-08-31
00816417021725CoolSculpting Support ArmZeltiq Aesthetics, Inc.CS-SA-COM-01-002020-08-31
10816417020091CoolGel MiniZeltiq Aesthetics, Inc.BRZ-GS1-000-0242016-09-23
10816417020114Pretreatment Skin WipeZeltiq Aesthetics, Inc.BRZ-PSW-000-0242016-09-23
00816417020537CoolSmooth PRO Securement PlateZeltiq Aesthetics, Inc.BRZ-SS4-09X-0122016-09-23
00816417020124Applicator AdapterZeltiq Aesthetics, Inc.BRZ-ADP-000-0002016-09-23
00816417020582Contour, CoolCore CoolAdvantageZeltiq Aesthetics, Inc.BRZ-CN1-160-0002016-09-23
00816417020605Contour, CoolFit CoolAdvantageZeltiq Aesthetics, Inc.BRZ-CN3-160-0002016-09-23
00816417020957Contour, CoolCurve+ CoolAdvantageZeltiq Aesthetics, Inc.BRZ-CN1-180-0002016-11-30
00816417020100Gel TrapZeltiq Aesthetics, Inc.BRZ-GT1-02X-0242016-09-23
00816417020650Gel Trap, CoolAdvantageZeltiq Aesthetics, Inc.BRZ-GT1-160-0242016-09-23
00816417020803CoolAdvantage Plus, GasketZeltiq Aesthetics, Inc.BRZ-LN1-180-0162016-10-07
00816417020889Gel Trap, CoolAdvantageZeltiq Aesthetics, Inc.BRZ-GT1-1X0-0082016-10-07
00816417020964Contour, CoolCore Plus, CoolAdvantage PlusZeltiq Aesthetics, Inc.BRZ-CN2-180-0002016-11-30
00816417021060CoolAdvantage Petite Gasket - 24 PackZeltiq Aesthetics, Inc.BRZ-LN2-140-0242017-07-15
00816417021084Contour, CoolCurve, CoolAdvantage PetiteZeltiq Aesthetics, Inc.BRZ-CN1-140-0002017-06-30
00816417021091Contour, CoolFit, CoolAdvantage PetiteZeltiq Aesthetics, Inc.BRZ-CN2-140-0002017-06-30
00816417021114CoolAdvantage Gasket- 8 PackZeltiq Aesthetics, Inc.BRZ-LN1-160-0082017-07-31
00816417021121CoolAdvantage Plus Gasket- 8 PackZeltiq Aesthetics, Inc.BRZ-LN1-180-0082017-07-31
00816417021138CoolAdvantage Petite Gasket- 8 PackZeltiq Aesthetics, Inc.BRZ-LN1-140-0082017-07-31
00816417021152Curve+ Contour, CoolAdvantage PetiteZeltiq Aesthetics, Inc.BRZ-CN3-140-0002017-08-31