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.

Clearance details

Applicant: Heidelberg Engineering GmbH
Product code: 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

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