510(k) K223557

SPECTRALIS HRA+OCT and variants by Heidelberg Engineering GmbH — Product Code OBO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 20, 2023
Date Received: November 25, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Tomography, Optical Coherence
Device Class: Class II
Regulation Number: 886.1570
Review Panel: OP
Submission Type

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

Other clearances by Heidelberg Engineering GmbH

K250868 — SPECTRALIS HRA+OCT and variants (May 12, 2025)
K240924 — Anterion (December 13, 2024)
K241163 — SPECTRALIS with Flex Module (October 11, 2024)
K240221 — SPECTRALIS HRA+OCT and variants (July 1, 2024)
K230897 — Anterion (October 11, 2023)
K211817 — Anterion (November 5, 2021)
K201252 — Spectralis HRA+OCT and variants (September 9, 2020)
K192391 — Spectralis HRA+OCT and Variants (September 26, 2019)
K182569 — Spectralis HRA+OCT and variants with High Magnification Module (October 18, 2018)
K181594 — Spectralis HRA+OCT and variants with OCT Angiography Module (September 13, 2018)

Other clearances for product code OBO

K252633 — UNITY DX (UDX) (December 23, 2025)
K250553 — Tomey Cornea/Anterior Segment OCT (CASIA2) (July 18, 2025)
K250868 — SPECTRALIS HRA+OCT and variants (May 12, 2025)
K240924 — Anterion (December 13, 2024)
K241163 — SPECTRALIS with Flex Module (October 11, 2024)
K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic (July 17, 2024)
K240221 — SPECTRALIS HRA+OCT and variants (July 1, 2024)
K233933 — CIRRUS HD-OCT Model 6000 (May 17, 2024)
K233602 — P200TE (A10700) (May 9, 2024)
K233561 — 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (April 10, 2024)