FDA Registration
Active
🇬🇧 United Kingdom
OPTOS PLC
Reg #: 9617167
·
FEI: 3003060634
·
Expires 2026
Products
5
Proprietary Names
18
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- OPTOS PLC
- Registration Number
- 9617167
- FEI Number
- 3003060634
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- QUEENSFERRY HOUSE, CARNEGIE CAMPUS, ENTERPRISE WAY
- City
- DUNFERMLINE, FIFE
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K162039
Owner / Operator
- Firm Name
- OPTOS PLC
- Operator Number
- 9035556
- Address
- QUEENSFERRY HOUSE, CARNEGIE, BUSINESS CAMPUS
- City
- DUNFERMLINE, FIFE
- State
- GB-NOTA
- Postal Code
- KY11 8GR
- Country
- GB
- Correspondent
- Alan K Leitch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Management, Ophthalmic | NFJ | Class 2 | Radiology | No | 2017-02-10 |
| Tomography, Optical Coherence | OBO | Class 2 | Ophthalmic | No | 2024-06-13 |
| Ophthalmoscope, Laser, Scanning | MYC | Class 2 | Ophthalmic | No | 2024-06-13 |
| Armrest, Wheelchair | IML | Class 1 | Physical Medicine | No | 2022-11-30 |
| Ophthalmoscope, Ac-Powered | HLI | Class 2 | Ophthalmic | No | 2006-12-19 |
Proprietary Names
Optos Advance 4
Monaco Pro
Monaco
P200TE
Silverstone RGB
Silverstone
P200TxE
Optos Arm rest
P200
200Dx
PANORAMIC
200Tx
Panoramic 200MAAF
California
Panoramic P200T (Daytona)
Daytona
Panoramic 200T
Optos Advance
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility