Cleared Traditional

K250868 - SPECTRALIS HRA+OCT and variants (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K250868 · Heidelberg Engineering GmbH · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
49d
Days
Class 2
Risk

K250868 is an FDA 510(k) clearance for the SPECTRALIS HRA+OCT and variants. Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Heidelberg Engineering GmbH (Heidelberg, DE). The FDA issued a Cleared decision on May 12, 2025 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Heidelberg Engineering GmbH devices

Submission Details

510(k) Number K250868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 110d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OBO Tomography, Optical Coherence
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Orasi Consulting, LLC
Lena Sattler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT04604002 Completed Observational Industry-sponsored

Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types

86
Patients (actual)
1
Site
Condition studied Retinal Vascular; Normal Eyes
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Principal investigator Dennis Marcus, MD
Sponsor Heidelberg Engineering GmbH (industry)
Started 2020-10-15 → Primary completion 2022-01-04
Primary outcome
Image quality score
Study completed - no results published. This trial concluded in 2022 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - OBO Tomography, Optical Coherence

All 64
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K250868.
UNITY DX (UDX)
K252633 · Cylite Pty. , Ltd. · Dec 2025
Tomey Cornea/Anterior Segment OCT (CASIA2)
K250553 · Tomey Corporation · Jul 2025
Anterion
K240924 · Heidelberg Engineering GmbH · Dec 2024
SPECTRALIS with Flex Module
K241163 · Heidelberg Engineering GmbH · Oct 2024
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)
K241081 · Topcon Corporation · Jul 2024
SPECTRALIS HRA+OCT and variants
K240221 · Heidelberg Engineering GmbH · Jul 2024