Optical Micro Systems, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Optical Micro Systems, Inc.” (first 1981, latest 1995), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 63 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 |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 6 | 6 |
| HQC | Unit, Phacofragmentation | 4 | 4 |
| KYG | Device, Irrigation, Ocular Surgery | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| HJI | Lens, Fundus, Hruby, Diagnostic | 1 | 1 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 1 | 1 |
| HMX | Cannula, Ophthalmic | 1 | 1 |
| HNM | Needle, Ophthalmic Suturing | 1 | 1 |
| HRJ | Table, Instrument, Powered, Ophthalmic | 1 | 1 |
| LWL | Fluid, Intraocular | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ophthalmic (18)
- General Hospital (1)
Most recent Optical Micro Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950218 | OMS SLIMLINE PHACO HANDPIECE | HQC | 1995-07-17 | 179 |
| K946054 | DIPLOMAX | HQC | 1995-07-11 | 211 |
| K935223 | OPHTHALMIC SURGICAL SYSTEM | HQC | 1994-03-14 | 133 |
| K935226 | I/V POLE | KYG | 1994-02-16 | 107 |
| K935003 | ELECTRIC I/V POLE OR EIVP2 | KYG | 1994-01-25 | 98 |
| K870068 | ASPIRATION REVERSAL CONTROL (ARC) MODULE | HQE | 1987-02-12 | 35 |
| K844373 | O.M.S. ULTRA-PHACO | HQC | 1985-12-19 | 401 |
| K844448 | OMS/GONVERS RETINAL PERFORATOR | HNM | 1985-08-21 | 278 |
| K844895 | OMS SILICONE OIL INJECTOR | LWL | 1985-06-24 | 189 |
| K844467 | OMS CRYO | — | 1985-02-22 | 95 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Optical Micro Systems, Inc..
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.
- Optical Sensors, Inc. (7 510(k)s)
- Optical Radiation Corp. (3 510(k)s)
- Optical Connection, Inc. (2 510(k)s)
- Optical Imaging , Ltd. (2 510(k)s)
- Optical Integrity, Inc. (2 510(k)s)
- Optical Polymer Research, Inc. (2 510(k)s)
- Optical Systems Intl., Inc. (2 510(k)s)
- Optical Center (1 510(k)s)
- Optical Coating Laboratory, Inc. (1 510(k)s)
- Optical Designs and Sourcing, Inc. (1 510(k)s)
- Optical Diagnostics, Inc. (1 510(k)s)
- Optical Moulding Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Optical Micro Systems, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Optical Micro Systems, Inc.” (first 1981, latest 1995), across 11 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 Optical Micro Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Optical Micro Systems, Inc. is 63 days.
Which FDA product codes appear under Optical Micro Systems, Inc.?
The most frequent FDA product codes under this applicant name are HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 6); HQC (Unit, Phacofragmentation, 4); KYG (Device, Irrigation, Ocular Surgery, 2).
Next steps
- See all 21 Optical Micro Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQE, Optical Micro Systems, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.