FDA.reportPublic FDA data

CoolSculpting Elite

Primary DI
00816417023767
Brand
CoolSculpting Elite
Company
Zeltiq Aesthetics, Inc.
Model
29901241
Device description
Card, ELITE, D, US, P3, 100Tx
Published
2026-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOKDermal Cooling Pack/Vacuum/Massager

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOKDermal Cooling Pack/Vacuum/MassagerGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233732000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233732000CoolSculpting Elite SystemZeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics2024-09-12OOK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816417023767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816417023767008164170237678164170237670816417023767

GMDN Terms#

Term, Definition table
TermDefinition
Cryolipolysis body contouring system applicatorA component of a cryolipolysis body contouring system designed to convey controlled cold from the system's control unit to the skin and subcutaneous tissues for cold-assisted lipolysis (coolsculpting). It is typically in the form of an articulated arm designed to hold a gel pad against the surface of the treatment site, and may also be used to apply vacuum to facilitate the treatment; optional pulsatile massage may also be applied. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
888-935-8471support@zeltiq.com

Regulatory Flags#

DUNS number
809152916
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816417022555CoolSculpting EliteCS-SG-S18-01-002026-05-22
00816417022579CoolSculpting EliteCS-FB-185-01-002026-05-22
00816417023088CoolSculpting EliteCS-A3018S-002026-05-22
00816417023538CoolSculpting EliteCS-GL-XLG-10-002026-05-22
00816417021510Gel Trap C80CS-GT-08C-10-002020-08-31
00816417022487CoolSculpting EliteCS-CS-D01-01-002026-03-27
00816417022746Curve 135 (C135) ApplicatorCS-A3-13C-00CS-A3-13C-002024-03-26
10816417020152CoolSmooth Foam Borders BRZ-FB1-09X-024 BRZ-FB1-09X-0242016-09-23
10816417020541CoolSmooth Securement SystemBRZ-SS1-09X-012BRZ-SS1-09X-0122016-09-23
10816417020558CoolSmooth Securement SystemBRZ-SS2-09X-012BRZ-SS2-09X-0122016-09-23
10816417020565CoolSmooth PRO Securement StrapsBRZ-SS3-09X-012BRZ-SS3-09X-0122016-09-23
10816417020671CoolAdvantage GasketBRZ-LN2-160-024BRZ-LN2-160-0242016-09-23
10816417020916CoolAdvantage Petite Gasket - 24 PackBRZ-LN1-140-024BRZ-LN1-140-0242017-03-15
00816417021329CoolSculpting Applicator Cable Support ArmBRZ-RP1-ARM-001BRZ-RP1-ARM-0012021-08-06
00816417021350CoolAdvantage Petite Comfort StrapBRZ-SS1-140-002BRZ-SS1-140-0022021-08-06
00816417022739CoolMini Support Arm SystemBRZ-RP2-ARM-001BRZ-RP2-ARM-0012021-08-06
00816417023064CoolMini Securement StrapsBRZ-SS7-02X-002BRZ-SS7-02X-0022021-08-06
00816417021664CoolSculpting Securement System Straps-SmallCS-SS-SM-02-00CS-SS-SM-02-002021-04-30
00816417022630CoolSculpting Elite Securement Grip, S150cs-ss-s15-02-00cs-ss-s15-02-002021-04-30
00816417021527CoolSculpting Quad Comfort StrapCS-SS-QD-02-00CS-SS-QD-02-002020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816417022555CoolSculpting EliteZeltiq Aesthetics, Inc.OOK2026-05-22
00816417022579CoolSculpting EliteZeltiq Aesthetics, Inc.OOK2026-05-22
00816417023088CoolSculpting EliteZeltiq Aesthetics, Inc.OOK2026-05-22
00816417023538CoolSculpting EliteZeltiq Aesthetics, Inc.OOK2026-05-22
00816417022487CoolSculpting EliteZeltiq Aesthetics, Inc.OOK2026-03-27
00816417022746Curve 135 (C135) ApplicatorZeltiq Aesthetics, Inc.OOK2024-03-26
00816417021008CoolCurve ApplicatorZeltiq Aesthetics, Inc.OOK2021-08-12
00816417021329CoolSculpting Applicator Cable Support ArmZeltiq Aesthetics, Inc.OOK2021-08-06
00816417021350CoolAdvantage Petite Comfort StrapZeltiq Aesthetics, Inc.OOK2021-08-06
00816417022739CoolMini Support Arm SystemZeltiq Aesthetics, Inc.OOK2021-08-06
00816417023064CoolMini Securement StrapsZeltiq Aesthetics, Inc.OOK2021-08-06
00816417022586CoolSculpting Umbilical Cable Assembly 2.3mZeltiq Aesthetics, Inc.OOK2021-06-15
00816417022593CoolSculpting Umbilical Cable Assembly 2.6mZeltiq Aesthetics, Inc.OOK2021-06-15
00816417021664CoolSculpting Securement System Straps-SmallZeltiq Aesthetics, Inc.OOK2021-04-30
00816417022609CoolSculpting Elite Card, Direct, US/CA, Solo,50TxZeltiq Aesthetics, Inc.OOK2021-04-30
00816417022630CoolSculpting Elite Securement Grip, S150Zeltiq Aesthetics, Inc.OOK2021-04-30
00816417022333CoolSculpting Elite Card, Direct, USA, CAN 10 Dual TXZeltiq Aesthetics, Inc.OOK2021-01-31
00816417022449CoolSculpting Elite Card, NFS, Direct, USA, CAN Solo 4 TxZeltiq Aesthetics, Inc.OOK2021-01-31
00816417022456CoolSculpting Elite Card, NFS, Direct, USA,CAN, Dual 4 TxZeltiq Aesthetics, Inc.OOK2021-01-31
00816417022463CoolSculpting Elite Card, Direct, USA, CAN 50 Dual TXZeltiq Aesthetics, Inc.OOK2021-01-31
00816417021343CoolSculpting Elite Quick-Check Card, 99 cycleZeltiq Aesthetics, Inc.OOK2020-12-09
00816417021381CoolSculpting Elite Card, Direct, USA,CAN 20 Solo TrxZeltiq Aesthetics, Inc.OOK2020-12-09
00816417021527CoolSculpting Quad Comfort StrapZeltiq Aesthetics, Inc.OOK2020-12-09
00816417021749CoolSculpting Elite Card, Direct, USA, CAN, 25 Dual TXZeltiq Aesthetics, Inc.OOK2020-12-09
00816417021756CoolSculpting Elite Card, Direct, USA, CAN 100 Solo TXZeltiq Aesthetics, Inc.OOK2020-12-09
00816417022302Foam Borders, S150 ApplicatorZeltiq Aesthetics, Inc.OOK2020-12-09
00816417022319S150 LinerZeltiq Aesthetics, Inc.OOK2020-12-09
00816417022470CoolSculpting Elite Card, Solo,NSF, ZA20-002Zeltiq Aesthetics, Inc.OOK2020-12-09
00816417021718CoolSculpting System Applicator Surface 150 (S150)Zeltiq Aesthetics, Inc.OOK2020-10-31
00816417021473CoolAdhesive Gel Pad (Small)Zeltiq Aesthetics, Inc.OOK2020-08-31