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Panoramic Ophthalmoscope

FDA UDI

Class II (US FDA UDI)

by Optos Public Limited Company

Identity

Trade Name
Panoramic Ophthalmoscope FDA UDI
Generic Name
Scanning-laser retinal imaging system FDA UDI
Model / Reference
P200 FDA UDI

Identifiers

Catalog Number
A1021 FDA UDI
Primary DI / UDI-DI
05057056010212 FDA UDI
510(k) Number
K983999 FDA UDI
FDA Product Code
HLI 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

Yes

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

Panoramic Ophthalmoscope 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Optos Public Limited Company

Sources (1)

  • FDA UDI 8e519dec-2581-41e8-9835-b130e23a43f8 36 fields · synced May 30, 2026