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Zeltiq Aesthetics, Inc.

United States·US-MF-000004536

Last updated September 17, 2026

Information

Country: United States
Address: 4410, Rosewood Drive, Pleasanton, California, United States
Website: www.coolsculpting.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1.925.621.7462
PRRC Contact: Maria Golovina
EUDAMED SRN: US-MF-000004536
FDA FEI Number: 3007215625
DUNS Number: 809152916

Catalogue (204)

Page 1 of 5

Device	Model / Reference	Registries	Class	Status
CoolAdhesive Pad	BRZ-GL3-160-008	FDA UDI	Class II	Active
CoolSculpting Elite Card, Direct, USA, CAN 10 Dual TX	CS-CD-D01-10-00	FDA UDI	Class II	Active
CoolSmooth PRO Card	BRZ-CD4-091-008	FDA UDI	Class II	Active
BODY 15mm Treatment Tip - 100 grit	C0293	FDA UDI	Class I	Active
CoolAdvantage Petite Card	BRZ-CD1-140-QCK	FDA UDI	Class II	Active
CoolSmooth PRO Card	BRZ-CD1-091-QCK	FDA UDI	Class II	Active
CoolSmooth Foam Borders	BRZ-FB1-09X-024	FDA UDI	Class II	Active
Contour, CoolCurve+ CoolAdvantage	BRZ-CN2-160-000	FDA UDI	Class II	Active
CoolAdvantage Card	BRZ-CD4-160-001	FDA UDI	Class II	Active
CoolSmooth Card	BRZ-CD4-09X-008	FDA UDI	Class II	Active
CoolAdvantage Petite	BRZ-AP2-140-000	FDA UDI	Class II	Active
CoolGel Mini	BRZ-GS1-000-024	FDA UDI	Class II	Active
BODY 15mm Adjustable Tip	C0227	FDA UDI	Class I	Active
CoolSmooth PRO Card	BRZ-CD4-091-003	FDA UDI	Class II	Active
CoolSmooth PRO Applicator	BRZ-AP1-091-001	FDA UDI	Class II	Active
Gel Trap, CoolAdvantage	BRZ-GT1-160-024	FDA UDI	Class II	Active
CoolMini Card	BRZ-CD4-02X-001	FDA UDI	Class II	Active
Standard Handpiece Tubing	A0054	FDA UDI	Class I	Active
BODY Handpiece 15mm	A0060	FDA UDI	Class I	Active
Plexus Diamond Handpiece Kit	A0261	FDA UDI	Class I	Active
Shallow Surface ZELTIQ Vacuum Applicator	BRZ-AP2-261-000	FDA UDI	Class II	Active
CoolAdvantage Petite Card	BRZ-CD4-140-001	FDA UDI	Class II	Active
CoolCore	BRZ-AP1-063-000	FDA UDI	Class II	Active
CoolAdhesive Plus Pad	BRZ-GL1-180-008	FDA UDI	Class II	Active
CoolAdvantage Petite Card	BRZ-CD4-140-003	FDA UDI	Class II	Unknown
Clear 6mm Disposable Caps	A0053	FDA UDI	Class I	Active
CoolSculpting Control Unit	BRZ-CG1-CUD-110	FDA UDI	Class II	Active
Twist-to-Lock Waste Jar	C2165	FDA UDI	Class I	Active
CoolMini Card	BRZ-CD4-02X-024	FDA UDI	Class II	Active
CoolAdvantage Plus Card	BRZ-CD4-180-008	FDA UDI	Class II	Active
CoolSmooth PRO Card	BRZ-CD4-091-024	FDA UDI	Class II	Active
Waste Jar - Clear 400ml	C0485	FDA UDI	Class I	Active
White Pore Clarifying Disposable Brushes	A0048	FDA UDI	Class I	Active
CoolAdhesive Gel Pad (Large)	CS-GL-LRG-10-00	FDA UDI	Class II	Active
CoolSmooth	BRZ-AP1-091-000	FDA UDI	Class II	Active
CoolSculpting Umbilical Cable Assembly 2.6m	CS-A3-UM4-00	FDA UDI	Class II	Active
CoolSmooth Liner	BRZ-LN1-09X-024	FDA UDI	Class II	Active
CoolAdvantage Petite Gasket - 24 Pack	BRZ-LN2-140-024	FDA UDI	Class II	Active
CoolAdvantage	BRZ-AP2-160-000	FDA UDI	Class II	Active
Diamond Treatment Tips	B0026	FDA UDI	Class I	Active
Body 15 mm Handpiece O-rings	A0078	FDA UDI	Class I	Active
SilkPeel Pro	A0029_ME	FDA UDI	Class I	Active
Pretreatment Skin Wipe	BRZ-PSW-000-024	FDA UDI	Class II	Active
CoolCard	BRZ-CD4-06X-012	FDA UDI	Class II	Active
Contour, CoolCurve+ CoolAdvantage	BRZ-CN1-180-000	FDA UDI	Class II	Active
CoolMini Card	BRZ-CD4-02X-008	FDA UDI	Class II	Active
CoolCard Max	BRZ-CD4-08X-008	FDA UDI	Class II	Active
CoolSculpting Elite Card, Direct, US/CA, Solo, 50Tx	CS-C2-D01-50-00	FDA UDI	Class II	Active
CoolAdhesive Petite Card	BRZ-CD4-140-003	FDA UDI	Class II	Active
CoolSculpting Control Unit, CDM - 110 VAC	BRZ-CG1-CDM-110	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Allergan Pharmaceuticals International Limited IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 9, 2022	Z-1348-2022	—	open, classified	Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.
Jun 9, 2022	Z-1346-2022	—	open, classified	Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.
Jun 9, 2022	Z-1349-2022	—	open, classified	Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.
Jun 9, 2022	Z-1350-2022	—	open, classified	Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.
Jun 9, 2022	Z-1347-2022	—	open, classified	Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.
Jul 5, 2021	Z-2383-2021	—	terminated	An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing a user to re-treating the affected anatomic area within 24 hours, 2) Not reporting a thermal event or any other error codes causing a user to continue treating without being aware that a thermal event has occurred.