FDA applicant
Optos Plc.
FDA records 15 decisions for Optos Plc. (Washington, DC) from 1999 to 2024: 15 510(k) clearances. Most are in product codes MYC (Ophthalmoscope, Laser, Scanning) and OBO (Tomography, Optical Coherence). Since 2016 its 510(k)s took a median of 132 days from receipt to decision, against 175 for FDA’s reviews in the same codes and years. Its devices cite 27 predicates, 14 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Optos Plc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Optos Plc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report