ALLERGAN SALES, LLC

FDA Device Registration & Listing · IRVINE, CA, US · Registration 2011068

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2011068
FEI Number
2011068
Entity Name
ALLERGAN SALES, LLC
City/State/Country
IRVINE, CA, US
Establishment Address
2525 DUPONT DR, IRVINE, CA 92612, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
AbbVie, Inc. (Owner Number: 2011068)
Owner / Operator Contact Address
2525 DUPONT DRIVE, --, Irvine, CA 92612, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K203229
PMA Number
N/A

All Registered Proprietary Names

Natrelle 133 Tissue Expander - Suture Tabs: 133 FV-T, 133 FX-T, 133 MV-T, 133 MX-T, 133 SV-T, 133 SX-T, 133 LV-T Natrelle 133 Tissue Expander with Suture Tabs Coolsculpting System Curve Resonic Console, Resonic, XEN Glaucoma Treatment System Juvederm Voluma XC Juvederm Volbella XC Juvederm Volux XC Juvederm Vollure XC Skinvive by Juvederm CoolSculpting Elite System CoolAdhesive Gel Pad Natrelle Saline-Filled Breast Implants: 10, 15, 20, 40, 45, 110, 115, 120 Natrelle Inspira Breast Implants: SRL, SRLP, SRM, SRF, SRX, TRF, TRL, TRLP, TRM, TRX, SSF, SSM, SSL, SSLP, SSX Natrelle Inspira Cohesive Breast Implants: SCF, SCL, SCLP, SCM, SCX, TCF, TCL, TCLP, TCM, TCX Coolsculpting System Juvederm Ultra Juvederm Ultra XC Juvederm Ultra Plus Juvederm 30 Juvederm Ultra Plus XC CoolSculpting Elite System SilkPeel Spa EnDoucer Dermolissage SilkPeel Pro SilkPeel MD DPRO SP3 Silk Peel Dermalinfusion Natrelle Inspira Re-ster Sizers: MSZ-F, MSZ-L, MSZ-LP, MSZ-M, MSZ-X, , MSZST-F, MSZST-L, MSZST-LP, MSZST-M, MSZST-X Natrelle410 Re-ster Sizers:MSZ-FL, MSZ-ML,MSZ-LL, MSZ-LM, MSZ-MX, MSZ-LF, MSZ-FX, MSZ-LX, MSZ-MM, MSZ-MF, MSZ-FM, MSZ-FF Natrelle Re-sterilizable Sizer: MSZ Natrelle Re-ster Sizers: MSZ-10, MSZ-15, MSZ-20, MSZ-45 Natrelle 133 Tissue Expander Natrelle 133 Tissue Expander No Suture Tabs: 133 FV, 133 FX, 133 MV, 133 MX, 133 SX, 133 SV, 133 LV emFieldPro Natrelle Saline-Filled Breast Implants Natrelle Saline-Filled Breast Implants - 68MP, 68HP, 68LP, 363LF, 163, 168, 468 Insertion Sleeve; Keller Funnel; Keller Funnel 2 Fill Tube Kit CUI Versafil Tissue Expanders Cool Tone System FOURTE Expander Fill System REFRESH® RELIEVA™ For CONTACTS Safsite Injection Site Reflux Valve Cool Micro Applicator NATRELLE INSPIRA Single Use Sizers for Gel Implants

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LCJ Tissue Expander And Accessories Unknown Class U N/A 2014-12-19
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2026-02-11
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2026-02-11
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2026-02-11
KYF Implant, Eye Valve Ophthalmic Class 2 886.3920 2017-01-04
LMH Implant, Dermal, For Aesthetic Use Unknown Class 3 N/A 2015-01-23
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2026-01-29
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2026-02-11
FTR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled General, Plastic Surgery Class 3 878.3540 2014-12-19
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2026-02-11
LMH Implant, Dermal, For Aesthetic Use Unknown Class 3 N/A 2015-01-23
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2026-02-11
GFE Brush, Dermabrasion, Powered General, Plastic Surgery Class 1 878.4820 2025-08-07
MRD Mammary Sizer Unknown Class U N/A 2014-12-19
LCJ Tissue Expander And Accessories Unknown Class U N/A 2014-12-19
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2026-02-11
FWM Prosthesis, Breast, Inflatable, Internal, Saline General, Plastic Surgery Class 3 878.3530 2014-12-19
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2015-01-23
LCJ Tissue Expander And Accessories Unknown Class U N/A 2014-12-19
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2026-02-11
LCJ Tissue Expander And Accessories Unknown Class U N/A 2017-06-14
LPN Accessories, Soft Lens Products Ophthalmic Class 2 886.5928 2019-08-23
MRC Products, Contact Lens Care, Rigid Gas Permeable Ophthalmic Class 2 886.5918 2019-08-23
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2018-03-08
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2026-02-11
MRD Mammary Sizer Unknown Class U N/A 2021-11-17

Official Correspondent

James Wabby

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AbbVie, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1643525 ALLERGAN SALES, LLC WACO, TX, US
3013307971 ABBVIE Logistics BV, Inc Zwolle Overijssel, NL
8020862 ALLERGAN PHARMACEUTICALS IRELAND WESTPORT Mayo, IE
3005113652 ALLERGAN Annecy Haute-Savoie, FR
1647098 LIFECELL CORP. BRANCHBURG, NJ, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K161483 Stradis Healthcare Unger Quad Injector 2016-10-31
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0006-04 N/A 3
McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561
Z-0028-05 Ciba Vision Corporation 2
SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2011068. Last updated year: 2026. Please use registration number 2011068 when referencing this establishment in official correspondence.
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