Advanced Medical Optics, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Advanced Medical Optics, Inc.” (first 2003, latest 2008), plus 10 PMA decisions, across 7 product codes in 1 review panel. Median 510(k) review time under this name: 100 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQL | Intraocular Lens | 8 | 0 |
| LPN | Accessories, Soft Lens Products | 3 | 3 |
| HQC | Unit, Phacofragmentation | 2 | 2 |
| LPM | Lenses, Soft Contact, Extended Wear | 2 | 0 |
| MLZ | Vitrectomy, Instrument Cutter | 1 | 1 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | 1 | 1 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 1 | 1 |
Review panels
- Ophthalmic (18)
Most recent Advanced Medical Optics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081681 | VITRECTOMY CUTTER AND ACCESSORIES | MLZ | 2008-10-08 | 113 |
| K081545 | ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 | MSS | 2008-10-02 | 122 |
| K060366 | THE AMO OPHTHALMIC SURGICAL SYSTEM | HQC | 2006-04-07 | 53 |
| K042562 | LENS PLUS REWETTING DROPS | LPN | 2005-07-29 | 311 |
| K050648 | SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK | HQC | 2005-04-05 | 22 |
| K040839 | COMPLETE BLINK-N-CLEAN LENS DROPS | MRC | 2004-10-19 | 202 |
| K032030 | BLINK CL LUBRICANT EYE DROPS | LPN | 2003-09-25 | 86 |
| K030092 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | LPN | 2003-04-04 | 84 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P940007 | PMA | PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL | 1995-07-20 |
| P890056 | PMA | MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS | 1994-05-26 |
| P880085 | PMA | MODEL 405 SPANFLEX TM IOL | 1991-06-27 |
| P860034 | PMA | MODEL AC-21 OMNIFIT ANTERIOR CHAMBER | 1989-09-29 |
| P860059 | PMA | MODEL 304 (ULTRA C-LOOP) | 1988-02-12 |
Recalls
17 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2008-10-29.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Medical Optics, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Advanced Medical Optics, Inc.” (first 2003, latest 2008), plus 10 PMA decisions, across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Advanced Medical Optics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Medical Optics, Inc. is 100 days.
Which FDA product codes appear under Advanced Medical Optics, Inc.?
The most frequent FDA product codes under this applicant name are HQL (Intraocular Lens, 8); LPN (Accessories, Soft Lens Products, 3); HQC (Unit, Phacofragmentation, 2).
Next steps
- See all 8 Advanced Medical Optics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQL, Advanced Medical Optics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.