← Back to catalogue

Ophthalmoscope

FDA UDI

Class II (US FDA UDI)

by Nidek, Inc.

Identity

Trade Name
OPHTHALMOSCOPE FDA UDI
Generic Name
Direct ophthalmoscope, line-powered FDA UDI
Device Name
The F-10 captures and records the confocal images of fundus by laser scanning using a selection of laser colors: IR (infrared), blue, green, and red. Indocyanine green (ICG) angiography and fluorescein angiography (FAG) are also possible. FDA UDI
Model / Reference
F-10 FDA UDI
Description
The F-10 captures and records the confocal images of fundus by laser scanning using a selection of laser colors: IR (infrared), blue, green, and red. Indocyanine green (ICG) angiography and fluorescein angiography (FAG) are also possible. FDA UDI

Identifiers

Primary DI / UDI-DI
04987669100561 FDA UDI
FDA Product Code
MYC FDA UDI
GMDN Term
Direct ophthalmoscope, line-powered 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

No

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

No

FDA UDI

Category: Direct ophthalmoscope, line-powered

Ophthalmoscope by Nidek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Direct ophthalmoscope, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nidek, Inc.

Sources (1)

  • FDA UDI 3091c2ad-24bd-4c94-b662-9f7c14c6c796 34 fields · synced Jun 8, 2026