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Optomed Smartscope M5 with Optomed Smartscope FA

by Optomed Oyj Finland EUDAMED510(k)

510(k) K201325 Product code HKI

Overview

The Optomed Smartscope M5 with Optomed Smartscope FA is an ophthalmic camera, ac-powered, non-mydriatic, designed for retinal imaging. It captures high-resolution images of the retina to aid in the diagnosis, monitoring, and management of eye conditions, including diabetic retinopathy and age-related macular degeneration.

This device is supplied as a reusable medical instrument, intended for use in clinical settings such as ophthalmology offices, hospitals, and retinal screening programs. It is regulated under the FDA 510(k) clearance, MDD, and MDR, with a classification of Class II. The device requires proper maintenance and calibration to ensure accurate imaging performance, and its use adheres to standard ophthalmic imaging protocols.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK201325 Date20 Nov 2020ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
HKI
Device Class
Class II
Regulation
21 CFR Part 886.1120
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What types of eye conditions is the Optomed Smartscope M5 with Optomed Smartscope FA primarily used to diagnose or monitor?

    The Optomed Smartscope M5 with Optomed Smartscope FA is designed for retinal imaging to aid in the diagnosis, monitoring, and management of specific eye conditions, including diabetic retinopathy and age-related macular degeneration. Its high-resolution imaging helps clinicians assess retinal health and track progression of these conditions over time.

  • Is the Optomed Smartscope M5 reusable, and if so, what maintenance is required to ensure proper function?

    Yes, the Optomed Smartscope M5 is a reusable medical instrument intended for clinical settings like ophthalmology offices and hospitals. To maintain accurate imaging performance, it requires proper maintenance and calibration as outlined in the manufacturer’s guidelines. Regular cleaning, servicing, and adherence to standard ophthalmic imaging protocols are essential for reliable operation.

  • How is the Optomed Smartscope M5 powered, and what clinical environments is it suitable for?

    The Optomed Smartscope M5 is ac-powered, meaning it requires access to an electrical outlet. This makes it ideal for clinical settings with stable power sources, such as ophthalmology offices, hospitals, and structured retinal screening programs where consistent imaging is required.

  • What regulatory pathways does the Optomed Smartscope M5 follow, and what classification does it hold?

    The device is regulated under FDA 510(k) clearance, the EU Medical Device Directive (MDD), and the EU Medical Device Regulation (MDR). It is classified as a Class II medical device, indicating it poses moderate risk and requires compliance with stringent manufacturing and performance standards.

Properties & raw data

Show properties, registry sources and raw records

Sources (2)

  • FDA 510(k) K201325 24 fields · synced 22 Oct 2026
  • EUDAMED 1 fields · synced 19 May 2026