Ophthalmic Technologies, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Ophthalmic Technologies, Inc.” (first 1995, latest 2005), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 49 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 | 5 |
| FTD | Lamp, Surgical | 1 | 1 |
| HLI | Ophthalmoscope, Ac-Powered | 1 | 1 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | 1 | 1 |
| MPA | Endoilluminator | 1 | 1 |
Review panels
- Radiology (5)
- Ophthalmic (3)
- General and Plastic Surgery (1)
Most recent Ophthalmic Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042885 | OCT-OPTHALMOSCOPE | HLI | 2005-01-21 | 94 |
| K031391 | HF MODULE WITH TRANSDUCERS | IYO | 2003-06-20 | 49 |
| K030770 | OTI SCAN WITH TRANSDUCERS | IYO | 2003-03-27 | 16 |
| K024114 | A-SCAN 100 | IYO | 2003-01-10 | 28 |
| K990064 | DI-RHEX OPHTHALMIC DIATHERMY SYSTEM | HQR | 1999-04-04 | 86 |
| K974522 | 3D I-SCAN | IYO | 1998-02-25 | 85 |
| K971679 | I-SCOPE OPHTHALMIC ENDOSCOPE | MPA | 1997-06-25 | 49 |
| K960622 | I-SCAN | IYO | 1996-05-13 | 90 |
| K954263 | XE-LITE | FTD | 1995-10-18 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Ophthalmic Technologies, 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.
- Ophthalmic Imaging Systems (5 510(k)s)
- Ophthalmic Consultants, Inc. (2 510(k)s)
- Ophthalmic Labs, Inc. (1 510(k)s)
- Ophthalmic Resources, Inc. (1 510(k)s)
- Ophthalmic Solutions, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ophthalmic Technologies, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Ophthalmic Technologies, Inc.” (first 1995, latest 2005), across 5 product codes in 3 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 Ophthalmic Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ophthalmic Technologies, Inc. is 49 days.
Which FDA product codes appear under Ophthalmic Technologies, Inc.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 5); FTD (Lamp, Surgical, 1); HLI (Ophthalmoscope, Ac-Powered, 1).
Next steps
- See all 9 Ophthalmic Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Ophthalmic Technologies, 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.