SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module— 510(k) K253837

Name: FDA 510(k) clearance K253837
Creator: U.S. Food and Drug Administration
Published: 2026-05-07

Substantially Equivalent

Heidelberg Engineering GmbH

FDA 510(k) clearance K253837 for SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module, Substantially Equivalent on 2026-05-07. Applicant: Heidelberg Engineering GmbH. Device class: 2.

Summary

Heidelberg Engineering's record names "SPECTRALIS HRA+OCT and variants" and "SPECTRALIS with Flex Module". The product code is OBO, optical coherence tomography. The record doesn't name the variants.

Class II, 21 CFR 886.1570. Ophthalmic is both the classification panel and the review panel. It was a Traditional 510(k).

Heidelberg Engineering filed from Heidelberg, Germany. The decision came 157 calendar days after receipt (December 1, 2025 to May 7, 2026).

Clearance details

Applicant: Heidelberg Engineering GmbH
Product code: Product code OBO
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2025-12-01
Decision date: 2026-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Heidelberg, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code OBO

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K261019 — ANTERION2026-09-11
K252633 — UNITY DX (UDX)2025-12-23
K250553 — Tomey Cornea/Anterior Segment OCT (CASIA2)2025-07-18
K250868 — SPECTRALIS HRA+OCT and variants2025-05-12
K240924 — Anterion2024-12-13

More clearances from Heidelberg Engineering GmbH

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K241163 — SPECTRALIS with Flex Module2024-10-11
K240221 — SPECTRALIS HRA+OCT and variants2024-07-01
K223557 — SPECTRALIS HRA+OCT and variants2023-10-20
K230897 — Anterion2023-10-11
K211817 — Anterion2021-11-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.