Allergan, Inc.: FDA clearances and approvals
Allergan, Inc. has 38 FDA 510(k) clearances (first 1982, latest 2021), plus 8 PMA and 1 De Novo decisions, across 20 product codes in 5 review panels. Median 510(k) review time: 75 days. Since 2017 its median was 212 days, against 166 days for all cleared 510(k)s in the same product codes. openFDA lists 5 product recalls by a recalling firm named Allergan, Inc. It is the industry lead sponsor of 61 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 203 |
| 2014 | 0 | — |
| 2015 | 1 | 269 |
| 2016 | 1 | 179 |
| 2017 | 0 | — |
| 2018 | 2 | 148 |
| 2019 | 1 | 146 |
| 2020 | 1 | 252 |
| 2021 | 1 | 212 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Allergan, Inc.'s cleared 510(k)s took a median 212 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 166 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPN | Accessories, Soft Lens Products | 12 | 12 |
| HPX | Lens, Contact (Polymethylmethacrylate) | 8 | 8 |
| HQC | Unit, Phacofragmentation | 3 | 3 |
| LCJ | Tissue Expander And Accessories | 3 | 3 |
| LMH | Implant, Dermal, For Aesthetic Use | 3 | 0 |
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | 2 | 0 |
| HNO | Keratome, Ac-Powered | 2 | 2 |
| QBR | Intranasal Electrostimulation Device For Dry Eye Symptoms | 2 | 1 |
| EIB | Syringe, Irrigating (Dental) | 1 | 1 |
| FWM | Prosthesis, Breast, Inflatable, Internal, Saline | 1 | 0 |
Plus 10 more product codes.
Review panels
- Ophthalmic (31)
- General and Plastic Surgery (12)
- Gastroenterology and Urology (2)
- Dental (1)
- Neurology (1)
Most recent Allergan, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203229 | NATRELLE INSPIRA Single Use Sizers for Gel Implants | MRD | 2021-06-02 | 212 |
| K193589 | TrueTear Intranasal Tear Neurostimulator | QBR | 2020-08-31 | 252 |
| K190674 | REFRESH RELIEVA For CONTACTS | LPN | 2019-08-08 | 146 |
| K180826 | Natrelle 133 Plus MICROCELL Tissue Expander | LCJ | 2018-12-21 | 266 |
| K182054 | Natrelle 133S Tissue Expander | LCJ | 2018-08-29 | 29 |
| K161457 | XEN Glaucoma Treatment System | KYF | 2016-11-21 | 179 |
| K143354 | Natrelle 133 Plus Tissue Expander | LCJ | 2015-08-20 | 269 |
| K123128 | SERI SURGICAL SCAFFOLD | OXF | 2013-04-25 | 203 |
| K083812 | REFRESH OPTIVE LENS COMFORT REWETTING DROPS | LPN | 2009-07-09 | 199 |
| K051852 | SINGLE AMPLIFIER FOR BOTOX | GWL | 2005-09-14 | 68 |
28 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170086 | De Novo | Intranasal Electrostimulation Device For Dry Eye Symptoms | 2018-05-17 |
| P110033 | PMA | JUVEDERM VOLUMA XC | 2013-10-22 |
| P040046 | PMA | NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS | 2013-02-20 |
| P020056 | PMA | NATRELLE SILICONE-FILLED BREAST IMPLANTS | 2006-11-17 |
| P050047 | PMA | JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS | 2006-06-02 |
Recalls
5 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2015-06-18.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Allergan, Inc. is the industry lead sponsor of 61 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04609020: Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment (Completed, started 2023-02-15)
- NCT05452070: A Study to Assess Adverse Events and Change in Disease Activity of HArmonyCa Lidocaine Injectable Gel for Mid Face Soft Tissue Augmentation in Adult Participants (Completed, started 2022-09-02)
- NCT05088980: Study to Assess Effectiveness and Adverse Events of JUVEDERM VOLBELLA With Lidocaine Injection in Correcting Infraorbital Hollowing in Chinese Adult Participants (Completed, started 2021-10-19)
- NCT05119777: HArmonyCa Injectable Gel for Mid Face Soft Tissue Augmentation (Completed, started 2021-10-13)
- NCT05077488: VFORM: Prospective, Open Label, Study to Evaluate VOLIFT With Lidocaine Treatment for FORehead Contouring and Marionette Lines (Completed, started 2021-09-15)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Allergan, Inc.'s product codes (a text match, not an official crosswalk):
- L8616 — Microphone for use with cochlear implant device, replacement (via LMH)
- L8615 — Headset/headpiece for use with cochlear implant device, replacement (via LMH)
- L8617 — Transmitting coil for use with cochlear implant device, replacement (via LMH)
Frequently asked questions
How many FDA 510(k) clearances does Allergan, Inc. have?
Allergan, Inc. has 38 FDA 510(k) clearances (first 1982, latest 2021), plus 8 PMA and 1 De Novo decisions, across 20 product codes in 5 review panels.
How long does FDA take to clear Allergan, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Allergan, Inc.'s cleared 510(k)s is 75 days. Since 2017: 212 days, versus 166 days for all cleared 510(k)s in the same product codes.
What devices does Allergan, Inc. make?
Its most frequent FDA product codes are LPN (Accessories, Soft Lens Products, 12); HPX (Lens, Contact (Polymethylmethacrylate), 8); HQC (Unit, Phacofragmentation, 3).
Has Allergan, Inc. had device recalls?
openFDA lists 5 product recalls in 4 recall events by a recalling firm whose name matches Allergan, Inc; the most recent began 2015-06-18. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 38 Allergan, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPN, Allergan, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.