Data / Medical devices / United States / Allergan Sales, LLC
Allergan Sales, LLC: FDA-registered device maker in Irvine, CA, United States, 24 510(k) clearances and 5 PMA approvals
Allergan Sales, LLC is registered with the FDA (registration 2011068) in Irvine, CA, United States. It lists 18 device types. The FDA files 24 510(k) clearances and 5 PMA approvals under its listings, the newest dated September 12, 2024. 7 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2011068
- Address
- 2525 Dupont DR, Irvine, CA, United States, 92612
- Owner or operator
- AbbVie, Inc. (2011068)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 4, 2000
- Registered through
- 2027
- Brand names listed
- CUI Versafil Tissue Expanders, Console, Resonic,, Cool Micro Applicator, Cool Tone System, CoolAdhesive Gel Pad, CoolAdvantage Petite Card, CoolSculpting Elite System, Coolsculpting System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 12, 2024 | K233732 | CoolSculpting Elite System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | accessdata.fda.gov |
| February 1, 2024 | K233804 | Resonic Rapid Acoustic Pulse Device | GEX | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| June 2, 2021 | K203229 | NATRELLE INSPIRA Single Use Sizers for Gel Implants | MRD | Substantially Equivalent | Allergan | accessdata.fda.gov |
| April 27, 2021 | K210964 | Resonic Rapid Acoustic Pulse Device | GEX | Substantially Equivalent | Soliton, Inc. | accessdata.fda.gov |
| January 21, 2020 | K193566 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| November 15, 2019 | K192940 | CoolTone | NGX | Substantially Equivalent | Zimmer Medizinsysteme GmbH | accessdata.fda.gov |
| August 8, 2019 | K190674 | REFRESH RELIEVA For CONTACTS | LPN | Substantially Equivalent | Allergan, Inc. | accessdata.fda.gov |
| June 21, 2019 | K182963 | emFieldPro | NGX | Substantially Equivalent | Zimmer Medizinsysteme GmbH | accessdata.fda.gov |
| January 14, 2019 | K183514 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| August 29, 2018 | K182054 | Natrelle 133S Tissue Expander | LCJ | Substantially Equivalent | Allergan | accessdata.fda.gov |
| August 29, 2018 | K181740 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| July 7, 2017 | K171069 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| November 21, 2016 | K161457 | XEN Glaucoma Treatment System | KYF | Substantially Equivalent | Allergan, Inc. | accessdata.fda.gov |
| October 31, 2016 | K161483 | Unger Quad Injector | LCJ | Substantially Equivalent | Stradis Healthcare | accessdata.fda.gov |
| March 23, 2016 | K160259 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| August 20, 2015 | K143354 | Natrelle 133 Plus Tissue Expander | LCJ | Substantially Equivalent | Allergan, Inc. | accessdata.fda.gov |
| January 5, 2011 | K102806 | NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS | LCJ | Substantially Equivalent | Allergan Medical | accessdata.fda.gov |
| May 20, 2009 | K090094 | ZELTIQ SYSTEM | GEX | Substantially Equivalent | Zeltiq Aesthetics | accessdata.fda.gov |
| October 7, 1999 | K992028 | REFRESH CONTACTS LUBRICATING AND REWETTING DROPS | LPN | Substantially Equivalent | Allergan, Inc. | accessdata.fda.gov |
| July 14, 1995 | K942988 | FILTERED EXTENSION SETS | FPA | Substantially Equivalent | B. Braun of America, Inc. | accessdata.fda.gov |
| May 22, 1987 | K865056 | CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER | LCJ | Substantially Equivalent | Cox-Uphuff Intl. | accessdata.fda.gov |
| July 23, 1986 | K862203 | MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER | LCJ | Substantially Equivalent | Mcghan Medical Corp. | accessdata.fda.gov |
| September 18, 1985 | K853014 | MCGHAN TISSUE EXPANDER FILL KIT | LCJ | Substantially Equivalent | Mcghan Medical Corp. | accessdata.fda.gov |
| August 12, 1983 | K831566 | CUI MAMMARY PROTHESIS SIZER | MRD | Substantially Equivalent | Cox-Uphuff Intl. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 22, 2013 | P110033 | JUVEDERM VOLUMA XC | LMH | 97 | August 28, 2026 | accessdata.fda.gov |
| February 20, 2013 | P040046 | NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS | FTR | 29 | July 26, 2021 | accessdata.fda.gov |
| November 17, 2006 | P020056 | NATRELLE SILICONE-FILLED BREAST IMPLANTS | FTR | 56 | September 29, 2026 | accessdata.fda.gov |
| June 2, 2006 | P050047 | JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS | LMH | 101 | August 28, 2026 | accessdata.fda.gov |
| May 10, 2000 | P990074 | NATRELLE SALINE BREAST IMPLANTS | FWM | 52 | December 16, 2024 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 14, 2024 | 94287 | Class II | Ongoing | Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only | Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure. | accessdata.fda.gov |
| December 29, 2020 | 87058 | Class II | Terminated | REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile | Missing Instruction For Use insert. | accessdata.fda.gov |
| November 6, 2019 | 84318 | Class III | Terminated | Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 10888628000513, NATRELLE Style 68LP-150 Saline Round L | The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard. | accessdata.fda.gov |
| October 30, 2019 | 84220 | Class II | Ongoing | XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment. | Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds could transfer to the patient's eye during procedure possibly resulting in irritation, inflammation, local allergic reaction/ hypersensitivity, iritis, uveitis/sterile endophthalmitis or an intraocula | accessdata.fda.gov |
| July 24, 2019 | 83500 | Class I | Ongoing | Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style 168:,,,,,,,,,,,,,,,,,,,; Style 3 | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants. | accessdata.fda.gov |
| June 18, 2015 | 71498 | Class II | Terminated | Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection un | Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life. | accessdata.fda.gov |
| June 8, 2015 | 71428 | Class II | Terminated | Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton. | Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level. | accessdata.fda.gov |
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Updated August 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.