Cleared Traditional

K240221 - SPECTRALIS HRA+OCT and variants (FDA 510(k) Clearance)

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

K240221 · Heidelberg Engineering GmbH · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
157d
Days
Class 2
Risk

K240221 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 July 1, 2024 after a review of 157 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Heidelberg Engineering GmbH devices

Submission Details

510(k) Number K240221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2024
Decision Date July 01, 2024
Days to Decision 157 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
47d slower than avg
Panel avg: 110d · This submission: 157d
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 K240221.
UNITY DX (UDX)
K252633 · Cylite Pty. , Ltd. · Dec 2025
Tomey Cornea/Anterior Segment OCT (CASIA2)
K250553 · Tomey Corporation · Jul 2025
SPECTRALIS HRA+OCT and variants
K250868 · Heidelberg Engineering GmbH · May 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