Cleared Traditional

SPECTRALIS HRA+OCT and variants

K250868 · Heidelberg Engineering GmbH · Ophthalmic

May 2025

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K250868 is an FDA 510(k) clearance for the SPECTRALIS HRA+OCT and variants, a Tomography, Optical Coherence (Class II — Special Controls, product code OBO), submitted by Heidelberg Engineering GmbH (Heidelberg, DE). The FDA issued a Cleared decision on May 12, 2025, 49 days after receiving the submission on March 24, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K250868 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 2025
Decision Date	May 12, 2025
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	OBO — Tomography, Optical Coherence
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.1570
Definition	Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.