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Spectralis HRA + OCT and Variants

by Heidelberg Engineering GmbH

510(k) K172649

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172649↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK172649 Date1 Nov 2017ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor
510(k) Number
FDA Product Code
OBO
Device Class
Class II
Regulation
21 CFR Part 886.1570
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Spectralis HRA + OCT and Variants are optical coherence tomography (OCT) devices designed for ophthalmic imaging. These systems integrate high-resolution retinal imaging with advanced modalities such as Fluorescein Angiography (FA), Indocyanine Green Angiography (ICGA), and MultiColor imaging to assess retinal structure and vasculature in detail. The devices provide cross-sectional and en-face visualization for diagnostic evaluation of retinal diseases, including macular degeneration, diabetic retinopathy, and glaucoma.

These systems are used in clinical ophthalmology settings and are supplied as reusable medical devices. The Spectralis platform supports modular upgrades, including Widefield Imaging and OCT Angiography, and operates under FDA 510(k) clearance and MDR authorization. Sterility is not applicable as these are non-sterile, reusable instruments intended for professional use in controlled environments. MRI safety and specific size configurations are determined by the installed modules and manufacturer specifications.

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