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US
Last updated May 30, 2026
What OPTOS PUBLIC LIMITED COMPANY makes
Optos Public Limited Company manufactures scanning-laser retinal imaging systems designed for detailed visualization of the retina. These devices include panoramic ophthalmoscopes and combined optical coherence tomography/swept-source laser ophthalmoscopy (OCT/SLO) systems, enabling high-resolution imaging of retinal structures. The portfolio also features image servers for processing and storing retinal scans, supporting clinical diagnostics and monitoring.
The company’s devices fall under Class II regulatory classification and are listed in the FDA’s Unique Device Identifier (UDI) database. These systems are intended for use in ophthalmic settings and comply with applicable medical device regulations in the United States. The manufacturer is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Optos Public Limited Company manufacture?
Optos Public Limited Company specializes in scanning-laser retinal imaging systems, including panoramic ophthalmoscopes and combined OCT/SLO (Optical Coherence Tomography/Swept-Source Laser Ophthalmoscopy) devices. These systems are designed to provide detailed, high-resolution imaging of the retina, aiding in clinical diagnostics and monitoring. The company also produces image servers for storing and processing retinal scan data.
Where is Optos Public Limited Company based?
Optos Public Limited Company is headquartered in the United States. This location aligns with its focus on developing and distributing retinal imaging technology primarily for the US market, though its devices may also be used internationally where applicable regulations permit.
Which regulatory registries list Optos’ devices?
Optos’ devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking for Class II medical devices. This registry is critical for healthcare providers and regulators to verify device details, such as specifications and regulatory status, when evaluating or using the technology.
How are Optos’ retinal imaging devices classified under medical device regulations?
Optos’ scanning-laser retinal imaging systems are classified as Class II devices under medical device regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as those used for diagnostic imaging where patient outcomes depend on accurate device performance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- optos.com
- —
- —
- [email protected]
- Phone
- +0441383843347
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 346013337
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Optos Advance Image Server | A10688 | FDA UDI | Class II | Active |
| Panoramic Ophthalmoscope | P200 | FDA UDI | Class II | Active |
| Optos OCT/SLO | OCT | FDA UDI | Class II | Active |
| Optos Advance Image Server | A10639 | FDA UDI | Class II | Active |
| Panoramic Opthalmoscope | 200Tx | FDA UDI | Class II | Active |
| Panoramic Ophthalmoscope | P200C | FDA UDI | Class II | Active |
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