Zeltiq Aesthetics Inc

FDA Filings

This page includes the latest FDA filings for Zeltiq Aesthetics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Zeltiq Aesthetics Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3013221323
FEI Number3013221323
NameKerrie Jiang
Owner & OperatorZELTIQ Aesthetics, Inc.
Contact Address4410 Rosewood Drive
Pleasanton CA 94588 US
Official Correspondent
  • Kerrie JIANG
  • x-650-7663968-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4410 Rosewood Drive
Pleasanton, CA 94588 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3011837770
FEI Number3011837770
NameZELTIQ AESTHETICS, INC.
Owner & OperatorZELTIQ Aesthetics, Inc.
Contact Address4410 Rosewood Drive
Pleasanton CA 94588 US
Official Correspondent
  • Kerrie JIANG
  • x-650-7663968-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7041 Las Positas Road
Livermore, CA 94551 US
Establishment TypeRepack or Relabel Medical Device



Registration Number3007215625
FEI Number3007215625
NameZELTIQ AESTHETICS, INC.
Owner & OperatorZELTIQ Aesthetics, Inc.
Contact Address4410 Rosewood Drive
Pleasanton CA 94588 US
Official Correspondent
  • Kerrie JIANG
  • x-650-7663968-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address4410 Rosewood Dr
Pleasanton, CA 94588 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198



Registration Number3009974688
FEI Number3009974688
NameZELTIQ AESTHETICS INC.
Owner & OperatorZELTIQ Aesthetics, Inc.
Contact Address4410 Rosewood Drive
Pleasanton CA 94588 US
Official Correspondent
  • Kerrie JIANG
  • x-650-7663968-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5996 Gleason Drive
Dublin, CA 94568 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device



Registration Number3014214244
FEI Number3014214244
NameZeltiq Aesthetics Inc
Owner & OperatorZELTIQ Aesthetics, Inc.
Contact Address4410 Rosewood Drive
Pleasanton CA 94588 US
Official Correspondent
  • Kerrie JIANG
  • x-650-7663968-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6723 Sierra Ct.
Dublin, CA 94568 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
Zeltiq Aesthetics, Inc.
CoolSculpting Elite System2021-11-05
Zeltiq Aesthetics, Inc.
CoolCurve Applicator BRZ-AP1-062-0002021-08-20
Zeltiq Aesthetics, Inc.
CoolMini Securement Straps BRZ-SS7-02X-0022021-08-16
Zeltiq Aesthetics, Inc.
CoolMini Support Arm System BRZ-RP2-ARM-0012021-08-16
Zeltiq Aesthetics, Inc.
CoolAdvantage Petite Comfort Strap BRZ-SS1-140-0022021-08-16
Zeltiq Aesthetics, Inc.
CoolSculpting Applicator Cable Support Arm BRZ-RP1-ARM-0012021-08-16
Zeltiq Aesthetics, Inc.
CoolSculpting Umbilical Cable Assembly 2.6m CS-A3-UM4-002021-06-23
Zeltiq Aesthetics, Inc.
CoolSculpting Umbilical Cable Assembly 2.3m CS-A3-UM3-002021-06-23
Zeltiq Aesthetics, Inc.
CoolSculpting Elite Securement Grip, S150 cs-ss-s15-02-002021-05-10
Zeltiq Aesthetics, Inc.
CoolSculpting Elite Card, Direct, US/CA, Solo,50Tx CS-C2-D01-50-002021-05-10
Zeltiq Aesthetics, Inc.
SPP Device, Dermalinfusion A00292021-05-10
Zeltiq Aesthetics, Inc.
CoolSculpting Securement System Straps-Small CS-SS-SM-02-002021-05-10
Zeltiq Aesthetics, Inc.
Body Handpiece 15mm A01952021-03-29
Zeltiq Aesthetics, Inc.
Plexus Diamond Handpiece Kit A02612021-03-29
Zeltiq Aesthetics, Inc.
Standard Diamond Handpiece Kit A02632021-03-29
Zeltiq Aesthetics, Inc.
BODY Diamond Treatment Tips B02112021-03-29
Zeltiq Aesthetics, Inc.
Diamond Treatment Tips B00262021-03-29
Zeltiq Aesthetics, Inc.
Plexus Pore Clarifying Handpiece Kit A02622021-03-29
Zeltiq Aesthetics, Inc.
Twist-to-Lock Waste Jar C21652021-03-29
Zeltiq Aesthetics, Inc.
Waste Jar - Clear 400ml C04852021-03-29
Zeltiq Aesthetics, Inc.
BODY 15mm Adjustable Tip C02272021-03-29
Zeltiq Aesthetics, Inc.
BODY 15mm Treatment Tip - 60 grit C02952021-03-29
Zeltiq Aesthetics, Inc.
BODY 15mm Treatment Tip - 80 grit C02942021-03-29
Zeltiq Aesthetics, Inc.
BODY 15mm Treatment Tip - 100 grit C02932021-03-29
Zeltiq Aesthetics, Inc.
BODY 15mm Treatment Tip - Smooth C02922021-03-29
Zeltiq Aesthetics, Inc.
Diamond 6mm Treatment Tip - 120 grit C20642021-03-29
Zeltiq Aesthetics, Inc.
Diamond 6mm Treatment Tip - 100 grit C20632021-03-29
Zeltiq Aesthetics, Inc.
Diamond 6 mm Treatment Tip - 80 grit C15932021-03-29
Zeltiq Aesthetics, Inc.
Diamond 6mm Treatment Tip - 60 grit C15922021-03-29
Zeltiq Aesthetics, Inc.
Diamond 6mm Treatment Tip - Smooth C13642021-03-29
Zeltiq Aesthetics, Inc.
Diamond 6mm Treatment Tip - 140 grit C08012021-03-29
Zeltiq Aesthetics, Inc.
Plexus Pore Clarifying Handpiece A01702021-03-29
Zeltiq Aesthetics, Inc.
BODY Handpiece 15mm A00602021-03-29
Zeltiq Aesthetics, Inc.
Coupler Set - Plastic B00432021-03-29
Zeltiq Aesthetics, Inc.
Plexus Diamond Handpiece A01692021-03-29
Zeltiq Aesthetics, Inc.
Standard Diamond Handpiece A01132021-03-29
Zeltiq Aesthetics, Inc.
Standard Handpiece Tubing A00542021-03-29
Zeltiq Aesthetics, Inc.
Plexus Handpiece Tubing A01772021-03-29
Zeltiq Aesthetics, Inc.
Plexus Handpiece O-Rings A01762021-03-29
Zeltiq Aesthetics, Inc.
Body 15 mm Handpiece O-rings A00782021-03-29
Zeltiq Aesthetics, Inc.
Clear 6mm Disposable Caps A00532021-03-29
Zeltiq Aesthetics, Inc.
Gray Pore Clarifying Disposable Brushes A00492021-03-29
Zeltiq Aesthetics, Inc.
White Pore Clarifying Disposable Brushes A00482021-03-29
Zeltiq Aesthetics, Inc.
Standard Handpiece O-Rings A00032021-03-29
Zeltiq Aesthetics, Inc.
DermalInfusion Pro A10022021-03-29
Zeltiq Aesthetics, Inc.
SilkPeel Pro A0029_ME2021-03-29
Zeltiq Aesthetics, Inc.
SP3 Dermalinfusion A01422021-03-29
Zeltiq Aesthetics, Inc.
SP3 DiamondGlow A0142_DG2021-03-29
Zeltiq Aesthetics, Inc.
CoolSculpting Elite Card, Direct, USA, CAN 50 Dual TX CS-CD-D01-50-002021-02-08
Zeltiq Aesthetics, Inc.
CoolSculpting Elite Card, NFS, Direct, USA,CAN, Dual 4 Tx CS-CT-D01-04-002021-02-08
Zeltiq Aesthetics, Inc.
CoolSculpting Elite Card, NFS, Direct, USA, CAN Solo 4 Tx CS-CS-D01-04-002021-02-08
Zeltiq Aesthetics, Inc.
CoolSculpting Elite Card, Direct, USA, CAN 10 Dual TX CS-CD-D01-10-002021-02-08
Zeltiq Aesthetics, Inc.
CoolSculpting Elite Card, Solo,NSF, ZA20-002 CS-CS-Z20-1C-022020-12-17
Zeltiq Aesthetics, Inc.
S150 Liner CS-LI-15S-01-002020-12-17
Zeltiq Aesthetics, Inc.
Foam Borders, S150 Applicator CS-FB-15S-01-002020-12-17
Zeltiq Aesthetics, Inc.
CoolSculpting Elite Card, Direct, USA, CAN 100 Solo TX CS-C2-D01-1C-002020-12-17
Zeltiq Aesthetics, Inc.
CoolSculpting Elite Card, Direct, USA, CAN, 25 Dual TX CS-CD-D01-25-002020-12-17
Zeltiq Aesthetics, Inc.
CoolSculpting Quad Comfort Strap CS-SS-QD-02-002020-12-17
Zeltiq Aesthetics, Inc.
CoolSculpting Elite Card, Direct, USA,CAN 20 Solo Trx CS-C2-D01-20-002020-12-17
Zeltiq Aesthetics, Inc.
CoolSculpting Elite Quick-Check Card, 99 cycle CS-CS-QCK-99-XX2020-12-17
Zeltiq Aesthetics, Inc.
CoolSculpting System Applicator Surface 150 (S150) 2020-11-09
Zeltiq Aesthetics, Inc.
CoolSculpting Umbilical Cable Assembly 1.2m 2020-09-08
Zeltiq Aesthetics, Inc.
CoolSculpting Support Arm 2020-09-08
Zeltiq Aesthetics, Inc.
CoolSculpting Umbilical Cable Assembly 1.5m 2020-09-08
Zeltiq Aesthetics, Inc.
CoolSculpting Umbilical Cable Assembly 2m 2020-09-08
Zeltiq Aesthetics, Inc.
CoolSculpting Securement Straps Extra Small 2020-09-08
Zeltiq Aesthetics, Inc.
CoolSculpting Securement System Straps - Medium 2020-09-08
Zeltiq Aesthetics, Inc.
CoolSculpting Securement System Straps Large 2020-09-08
Zeltiq Aesthetics, Inc.
CoolSculpting Securement Strap Extra Large 2020-09-08
Zeltiq Aesthetics, Inc.
Pre-Treatment Skin Wipe 2020-09-08
Zeltiq Aesthetics, Inc.
CoolSculpting Elite Control Unit 2020-09-08
Zeltiq Aesthetics, Inc.
CoolSculpting System Applicator Flat 165 (F165) 2020-09-08
Zeltiq Aesthetics, Inc.
CoolSculpting System Applicator Curved 240 (C240) 2020-09-08
Zeltiq Aesthetics, Inc.
CoolSculpting System Applicator Flat 125 (F125) 2020-09-08
Zeltiq Aesthetics, Inc.
CoolSculpting System Applicator Curve 120 (C120) 2020-09-08
Zeltiq Aesthetics, Inc.
CoolSculpting System Applicator Curve 150 (C150) 2020-09-08
Zeltiq Aesthetics, Inc.
CoolSculpting System Applicators Curve 80 (C80) 2020-09-08
Zeltiq Aesthetics, Inc.
Gel Trap V3 2020-09-08
Zeltiq Aesthetics, Inc.
Gel Trap C80 2020-09-08
Zeltiq Aesthetics, Inc.
CoolAdhesive Gel Pad (Large) 2020-09-08
Zeltiq Aesthetics, Inc.
CoolAdhesive Gel Pad (Medium) 2020-09-08
Zeltiq Aesthetics, Inc.
CoolAdhesive Gel Pad (Small) 2020-09-08
Zeltiq Aesthetics, Inc.
CoolGel Mini BRZ-GS1-000-0242020-05-21
Zeltiq Aesthetics, Inc.
Pretreatment Skin Wipe BRZ-PSW-000-0242020-05-18
Zeltiq Aesthetics, Inc.
CoolMini Liner BRZ-LN1-02X-0242020-05-18
Zeltiq Aesthetics, Inc.
Pretreatment Skin Wipes 2020-05-04
Zeltiq Aesthetics, Inc.
CoolSmooth PRO Securement Plate BRZ-SS4-09X-0122020-05-04
Zeltiq Aesthetics, Inc.
CoolAdvantage Petite Card BRZ-CD4-140-0032020-01-30
ZELTIQ Aesthetics, Inc.
ZELTIQ CoolSculpting System2020-01-21
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
SilkPeel Spa2020-01-16
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
SilkPeel Pro2020-01-16
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
SilkPeel MD2020-01-16
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
Silk Peel Dermalinfusion2020-01-16
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
SP32020-01-16
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
EnDoucer Dermolissage2020-01-16
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
DPRO2020-01-16
Zeltiq Aesthetics, Inc.
CoolSculpting Solo 2019-11-15
Zeltiq Aesthetics, Inc.
CoolAdvantage Core 2019-11-15
Zeltiq Aesthetics, Inc.
CoolAdvantage Petite Core 2019-11-15
Zeltiq Aesthetics, Inc.
CoolSculpting Card, 100 Cycle 2019-11-13
Zeltiq Aesthetics, Inc.
CoolAdvantage Card, 25, 25 Minutes 2019-11-13
ZELTIQ AESTHETICS, INC.
CoolSculpting System2019-10-07
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
CoolSculpting System2019-10-07
Kerrie Jiang [ZELTIQ Aesthetics, Inc.]
REVOLVE2019-03-01
ZELTIQ Aesthetics, Inc.
ZELTIQ CoolSculpting System2019-01-14
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
TrueTear Intranasal Tear Neurostimulator2018-10-19
Zeltiq Aesthetics Inc [ZELTIQ Aesthetics, Inc.]
CoolSculpting System2018-09-21
Zeltiq Aesthetics Inc [ZELTIQ Aesthetics, Inc.]
Accessories: applicator, card, gelpad, gel, gel trap, foam border, liner, strap, skin wipe, gasket, contour2018-09-21
ZELTIQ AESTHETICS, INC.
CoolSculpting System2018-09-21
ZELTIQ AESTHETICS, INC.
Accessories: applicator, card, gelpad, gel, gel trap, foam border, liner, strap, skin wipe, gasket, contour2018-09-21
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
CoolSculpting System2018-09-21
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
Accessories: applicator, card, gelpad, gel, gel trap, foam border, liner, strap, skin wipe, gasket, contour2018-09-21
Kerrie Jiang [ZELTIQ Aesthetics, Inc.]
CoolSculpting System2018-09-21
Kerrie Jiang [ZELTIQ Aesthetics, Inc.]
Accessories: applicator, card, gelpad, gel, gel trap, foam border, liner, strap, skin wipe, gasket, contour2018-09-21
Zeltiq Aesthetics, Inc.
CoolMicro Applicator 2018-09-12
Zeltiq Aesthetics, Inc.
Sealed CoolMini Applicator 2018-09-12
ZELTIQ Aesthetics, Inc.
ZELTIQ CoolSculpting System2018-08-29
Zeltiq Aesthetics, Inc.
Gel Trap BRZ-GT1-02X-0242018-03-29
Zeltiq Aesthetics, Inc.
CoolMini Card BRZ-CD4-02X-0242018-03-29
Zeltiq Aesthetics, Inc.
CoolMini BRZ-AP2-020-0002018-03-29
Zeltiq Aesthetics, Inc.
CoolSculpting Base Module BRZ-CG1-BAM-1102018-03-29
Zeltiq Aesthetics, Inc.
CoolSculpting Upper Module BRZ-CG1-UMD-0002018-03-29
Zeltiq Aesthetics, Inc.
CoolSculpting Control Unit BRZ-CG1-CUD-1102018-03-29
Zeltiq Aesthetics Inc [ZELTIQ Aesthetics, Inc.]
CoolSculpting System2018-02-05
ZELTIQ AESTHETICS, INC.
CoolSculpting System2018-02-05
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
CoolSculpting System2018-02-05
Kerrie Jiang [ZELTIQ Aesthetics, Inc.]
CoolSculpting System2018-02-05
ZELTIQ Aesthetics, Inc.
ZELTIQ CoolSculpting System2017-07-07
ZELTIQ Aesthetics, Inc
ZELTIQ CoolSculpting System2016-11-21
ZELTIQ AESTHETICS, INC.
ZELTIQ CoolSculpting System2016-03-23
Zeltiq Aesthetics Inc [ZELTIQ Aesthetics, Inc.]
CoolSculpting System2015-12-02
ZELTIQ AESTHETICS, INC.
CoolSculpting System2015-12-02
ZELTIQ AESTHETICS, INC.
CoolSculpting System2015-12-02
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
CoolSculpting System2015-12-02
ZELTIQ AESTHETICS, INC.
ZELTIQ CoolSculpting System2015-09-22
ZELTIQ AESTHETICS, INC.
ZEL TIQ CoolSculpting System2015-01-26
Zeltiq Aesthetics Inc [ZELTIQ Aesthetics, Inc.]
CoolSmooth2014-04-25
Zeltiq Aesthetics Inc [ZELTIQ Aesthetics, Inc.]
CoolSculpting System2014-04-25
ZELTIQ AESTHETICS, INC.
CoolSmooth2014-04-25
ZELTIQ AESTHETICS, INC.
CoolSculpting System2014-04-25
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
CoolSmooth2014-04-25
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
CoolSculpting System2014-04-25
ZELTIQ AESTHETICS, INC.
ZELTIQ COOLSCULPTING SYSTEM2014-04-09
Zeltiq Aesthetics Inc [ZELTIQ Aesthetics, Inc.]
ZELTIQ Breeze System2013-01-14
Zeltiq Aesthetics Inc [ZELTIQ Aesthetics, Inc.]
CoolSculpting System2013-01-14
ZELTIQ AESTHETICS, INC.
ZELTIQ Breeze System2013-01-14
ZELTIQ AESTHETICS, INC.
CoolSculpting System2013-01-14
ZELTIQ AESTHETICS, INC.
ZELTIQ COOLSCULPTING2012-05-02
Zeltiq Aesthetics Inc [ZELTIQ Aesthetics, Inc.]
ZELTIQ System2010-12-17
Zeltiq Aesthetics Inc [ZELTIQ Aesthetics, Inc.]
CoolSculpting System2010-12-17
ZELTIQ AESTHETICS, INC.
ZELTIQ System2010-12-17
ZELTIQ AESTHETICS, INC.
CoolSculpting System2010-12-17
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
ZELTIQ System2010-12-17
ZELTIQ AESTHETICS INC. [ZELTIQ Aesthetics, Inc.]
CoolSculpting System2010-12-17
Zeltiq Aesthetics Inc [ZELTIQ Aesthetics, Inc.]
Zeltiq System2009-06-03
ZELTIQ AESTHETICS, INC.
Zeltiq System2009-06-03
Zeltiq Aesthetics Inc [ZELTIQ Aesthetics, Inc.]
Zeltiq System2009-06-03
ZELTIQ AESTHETICS, INC.
Zeltiq System2009-06-03
Zeltiq Aesthetics Inc [ZELTIQ Aesthetics, Inc.]
Zeltiq System2009-06-03
ZELTIQ AESTHETICS, INC.
Zeltiq System2009-06-03

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
20200929105685Bremerhaven,Federal Republic of Germany -> Houston, TexasMEDICAL THERAPY EQUIPMENT COOL TONE HS-CODE 9018 908428 PKG
2020092459664Bremerhaven,Federal Republic of Germany -> Houston, TexasMEDICAL THERAPY EQUIPMENT COOL TONE HS-CODE 9018 908428 PKG
2020092321397Stadersand,Federal Republic of Germany -> Houston, TexasMEDICAL THERAPY EQUIPMENT COOL TONE HS-CODE 9018 908426 PKG
2020092382507Bremerhaven,Federal Republic of Germany -> Houston, TexasMEDICAL THERAPY EQUIPMENT COOL TONE HS-CODE 9018 908428 PKG
2020091933041Stadersand,Federal Republic of Germany -> Houston, TexasMEDICAL THERAPY EQUIPMENT COOL TONE HS-CODE 9018 908426 PKG
2020091826147Stadersand,Federal Republic of Germany -> Houston, TexasMEDICAL THERAPY EQUIPMENT COOL TONE HS-CODE 9018 908426 PKG
2020091753002Stadersand,Federal Republic of Germany -> Houston, TexasMEDICAL THERAPY EQUIPMENT COOL TONE HS-CODE 9018 908426 PKG
202009056838Stadersand,Federal Republic of Germany -> Houston, TexasMEDICAL THERAPY EQUIPMENT COOL TONE HS-CODE 9018 908430 PKG

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