Identity
- Trade Name
- Optos OCT/SLO FDA UDI
- Generic Name
- Scanning-laser retinal imaging system FDA UDI
- Model / Reference
- OCT FDA UDI
Identifiers
- Catalog Number
- 000385 FDA UDI
- Primary DI / UDI-DI
- 05057056003856 FDA UDI
- 510(k) Number
- K080460 FDA UDI
- FDA Product Code
- OBO FDA UDI
- GMDN Term
- Scanning-laser retinal imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Scanning-laser retinal imaging system
Optos OCT/SLO by Optos Public Limited Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scanning-laser retinal imaging system.
- SPECTRALIS — Heidelberg Engineering · Class II
- SPECTRALIS — Heidelberg Engineering · Class II
- SPECTRALIS — Heidelberg Engineering · Class II
- SPECTRALIS — Heidelberg Engineering · Class II
- SPECTRALIS — Heidelberg Engineering · Class II
- Laser Speckle Flowgraphy LSFG-NAVI — Softcare Co., Ltd. · Class II
- SPECTRALIS — Heidelberg Engineering · Class II
- SPECTRALIS — Heidelberg Engineering · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Optos Public Limited Company
Sources (1)
- FDA UDI b96bd9d0-06e9-4eb8-9878-3a7b66a0cad8 36 fields · synced May 30, 2026