American Medical Optics: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “American Medical Optics” (first 1982, latest 1986), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 48 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| HQF | Laser, Ophthalmic | 5 | 5 |
| HLI | Ophthalmoscope, Ac-Powered | 3 | 3 |
| HQC | Unit, Phacofragmentation | 2 | 2 |
| HJA | Photokeratoscope | 1 | 1 |
| HNO | Keratome, Ac-Powered | 1 | 1 |
| HQB | Photocoagulator And Accessories | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
| HQL | Intraocular Lens | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| KYB | Lens, Guide, Intraocular | 1 | 1 |
Review panels
- Ophthalmic (16)
- Radiology (1)
Most recent American Medical Optics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K860001 | BARRAQUER-KRUMEICH REFRACTIVE SET | HNO | 1986-02-04 | 33 |
| K851264 | AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS | HLI | 1985-05-01 | 34 |
| K851263 | AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP | HLI | 1985-05-01 | 34 |
| K851262 | AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA | HLI | 1985-04-30 | 33 |
| K844150 | MEDICAL OPTICS PHACOEMULSIFICATION KIT | HQC | 1984-12-11 | 48 |
| K843966 | ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS | HQB | 1984-11-08 | 28 |
| K843965 | ARGON LASER PHOTOCOAGULATOR SYS | HQF | 1984-11-06 | 26 |
| K842504 | AMER. MEDICAL OPTICS DIGITAL KERATO- | HQL | 1984-10-01 | 97 |
| K842197 | AMERICAN MEDICAL OPTICS I/A KIT- IRRIG | HQE | 1984-10-01 | 119 |
| K842127 | AMERICAN MEDICAL OPTICS IMAGING SYS | IYO | 1984-09-07 | 101 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Medical Optics.
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.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Medical Optics?
FDA lists 17 510(k) clearances under the applicant name “American Medical Optics” (first 1982, latest 1986), across 10 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by American Medical Optics?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Medical Optics is 48 days.
Which FDA product codes appear under American Medical Optics?
The most frequent FDA product codes under this applicant name are HQF (Laser, Ophthalmic, 5); HLI (Ophthalmoscope, Ac-Powered, 3); HQC (Unit, Phacofragmentation, 2).
Next steps
- See all 17 American Medical Optics clearances with predicates and recalls
- Run predicate analysis for product code HQF, American Medical Optics'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.