Optos Plc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Optos Plc.” (first 1999, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 101 days. Since 2017 the median was 132 days, against 141 days for all cleared 510(k)s in the same product codes. 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 | 1 | 161 |
| 2013 | 1 | 323 |
| 2014 | 1 | 101 |
| 2015 | 1 | 105 |
| 2016 | 0 | — |
| 2017 | 1 | 201 |
| 2018 | 1 | 86 |
| 2019 | 1 | 132 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 71 |
| 2024 | 1 | 182 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Optos Plc. took a median 132 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 141 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MYC | Ophthalmoscope, Laser, Scanning | 6 | 6 |
| OBO | Tomography, Optical Coherence | 5 | 5 |
| HLI | Ophthalmoscope, Ac-Powered | 2 | 2 |
| NFJ | System, Image Management, Ophthalmic | 2 | 2 |
Review panels
- Ophthalmic (15)
Most recent Optos Plc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233602 | P200TE (A10700) | OBO | 2024-05-09 | 182 |
| K231673 | P200TE (A10700) | OBO | 2023-08-18 | 71 |
| K190732 | P200TxE | OBO | 2019-07-31 | 132 |
| K173707 | P200TE | OBO | 2018-02-28 | 86 |
| K162039 | OptosAdvance 4.0 Software | NFJ | 2017-02-08 | 201 |
| K142897 | P200DTx | MYC | 2015-01-16 | 105 |
| K134039 | DAYTONA ICG (P200TICG) | MYC | 2014-04-11 | 101 |
| K121043 | OPTOS OCT/SLO MICROPERIMETER | OBO | 2013-02-22 | 323 |
| K113696 | OPTOS ADVANCE | NFJ | 2012-05-25 | 161 |
| K111628 | P200T | MYC | 2011-08-19 | 70 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Optos Plc..
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.
Device clinical trials
An industry sponsor named Optos Plc. is the lead sponsor of 9 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07149740: Data Gathering for A10900 (Recruiting, started 2025-06-26)
- NCT06305481: Glaucoma Evaluation With the P200TE (Completed, started 2024-02-13)
- NCT06269666: P200TxE Diseased Eye Image Collection (Recruiting, started 2024-01-31)
- NCT05532410: Optic Disc Photograph Collection Study (Completed, started 2022-09-02)
- NCT03964831: Study Comparing the P200TxE and P200DTx (Completed, started 2019-06-18)
Frequently asked questions
How many FDA 510(k) clearances are listed under Optos Plc.?
FDA lists 15 510(k) clearances under the applicant name “Optos Plc.” (first 1999, latest 2024), across 4 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 Optos Plc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Optos Plc. is 101 days. Since 2017: 132 days, versus 141 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Optos Plc.?
The most frequent FDA product codes under this applicant name are MYC (Ophthalmoscope, Laser, Scanning, 6); OBO (Tomography, Optical Coherence, 5); HLI (Ophthalmoscope, Ac-Powered, 2).
Next steps
- See all 15 Optos Plc. clearances with predicates and recalls
- Run predicate analysis for product code MYC, Optos Plc.'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.