FDA Registration
Active
🇺🇸 United States
ALLERGAN SALES, LLC
Reg #: 2011068
·
FEI: 2011068
·
Expires 2026
Products
18
Proprietary Names
59
Establishment Types
2
Classifications
18
Registration Details
- Registration Name
- ALLERGAN SALES, LLC
- Registration Number
- 2011068
- FEI Number
- 2011068
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2525 DUPONT DR
- City
- IRVINE
- State
- CA
- ZIP
- 92612
- Country
- US
Regulatory Submissions
- 510(k) Number
- K102806
- PMA Number
- P110033
Owner / Operator
- Firm Name
- AbbVie, Inc.
- Operator Number
- 2011068
- Address
- 2525 DUPONT DRIVE, --
- City
- Irvine
- State
- CA
- Postal Code
- 92612
- Country
- US
- Correspondent
- James P Wabby
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tissue Expander And Accessories | LCJ | Class U | Unknown | No | 2014-12-19 |
| Dermal Cooling Pack/Vacuum/Massager | OOK | Class 2 | General, Plastic Surgery | No | 2026-02-11 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2026-02-11 |
| Implant, Eye Valve | KYF | Class 2 | Ophthalmic | No | 2017-01-04 |
| Implant, Dermal, For Aesthetic Use | LMH | Class 3 | Unknown | No | 2015-01-23 |
| Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | FTR | Class 3 | General, Plastic Surgery | No | 2014-12-19 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2025-08-07 |
| Mammary Sizer | MRD | Class U | Unknown | No | 2014-12-19 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2026-02-11 |
| Prosthesis, Breast, Inflatable, Internal, Saline | FWM | Class 3 | General, Plastic Surgery | No | 2014-12-19 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2015-01-23 |
| Accessories, Soft Lens Products | LPN | Class 2 | Ophthalmic | No | 2019-08-23 |
| Products, Contact Lens Care, Rigid Gas Permeable | MRC | Class 2 | Ophthalmic | No | 2019-08-23 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2018-03-08 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2026-02-11 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2026-02-11 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2016-01-28 |
| Template | HWT | Class 1 | Orthopedic | No | 2015-01-23 |
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
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
Refresh Contacts
Natrelle 133S Tissue Expander Styles: S-FV, S-FX, S-MV, S-MX, S-SX, S-SV
Natrelle 133S Tissue Expander Styles: 133S FV-T, 133S FX-T, 133S MV-T, 133S MX-T, 133S SV-T, 133S SX-T, 133S LV-T
MagnaFinder Xact
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants: FF,FM,FL,MF,MM, ML,LF,LM,LL,FX,MX,LX
Natrelle 133 Plus Tissue Expander
Natrelle 133 Plus Tissue Expander - 133P FV, 133P FX, 133P MV, 133P MX, 133P SX, 133P SV, 133P LV
CoolAdvantage Petite Card
Skin Marking Grid
Style 133 Series Templates
Infusion Set, Universal Fill Kit, Winged Infusion Set
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility