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SPECTRALIS HRA+OCT and variants

by Heidelberg Engineering GmbH Germany 510(k)

510(k) K223557 Product code OBO

Overview

SPECTRALIS HRA+OCT and variants is a multimodal imaging platform that combines confocal scanning laser ophthalmoscopy with spectral domain optical coherence tomography (OCT). It is designed for imaging the posterior segment of the eye.

The device is supplied as a reusable system for use in clinical ophthalmic settings. It has received FDA 510(k) clearance (K223557) and is classified as a Class II medical device under regulation number 886.1570 with product code OBO.

Summary written by AI from registry data, 24 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 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK223557 Date20 Oct 2023ClearedStatusActive

Coverage

1 jurisdiction

United 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 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 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 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 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

United States — FDA 510(k) Active

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

Specification

510(k) · synced 22 Oct 2026

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

Other devices from Heidelberg Engineering GmbH

See all devices from Heidelberg Engineering GmbH →

Questions

  • What is the SPECTRALIS HRA+OCT used for?

    The SPECTRALIS HRA+OCT is designed for imaging the posterior segment of the eye by combining confocal scanning laser ophthalmoscopy with spectral domain optical coherence tomography (OCT). This multimodal capability allows clinicians to obtain detailed structural and functional images of the retina and optic nerve in a single platform, supporting diagnosis and monitoring of retinal diseases.

  • Is the SPECTRALIS HRA+OCT a single-use or reusable device?

    The SPECTRALIS HRA+OCT is supplied as a reusable system intended for use in clinical ophthalmic settings. It is not a single-use device; instead, it is designed for repeated use with proper cleaning and maintenance between patient examinations, consistent with its classification as a reusable imaging platform.

  • What regulatory clearance does the SPECTRALIS HRA+OCT have?

    The SPECTRALIS HRA+OCT has received FDA 510(k) clearance under submission number K223557, which was granted on October 20, 2023. It is classified as a Class II medical device under regulation 886.1570 with product code OBO, indicating it is substantially equivalent to a legally marketed predicate device.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K223557 24 fields · synced 22 Oct 2026