Cleared Traditional

Spectralis HRA+OCT and variants with OCT Angiography Module (K181594) - FDA 510(k) Clearance

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

K181594 · Heidelberg Engineering GmbH · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
87d
Days
Class 2
Risk

K181594 is an FDA 510(k) clearance for the Spectralis HRA+OCT and variants with OCT Angiography Module. 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 September 13, 2018 after a review of 87 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 K181594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2018
Decision Date September 13, 2018
Days to Decision 87 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
23d faster than avg
Panel avg: 110d · This submission: 87d
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
NCT03279939 Completed Observational Industry-sponsored

Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

88
Patients (actual)
1
Site
Condition studied Retinal Vascular; Normal Eyes
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Principal investigator David Brown, MD
Sponsor Heidelberg Engineering GmbH (industry)
Started 2017-08-23 → Primary completion 2018-01-12
Primary outcome
OCTA image quality
Study completed - no results published. This trial concluded in 2018 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. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - OBO Tomography, Optical Coherence

All 34
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K181594.
CIRRUS HD-OCT
K181534 · Carl Zeiss Meditec, Inc. · Feb 2019
RESCAN 700, CALLISTO eye
K180229 · Carl Zeiss Meditec, AG · Jan 2019
Spectralis HRA+OCT and variants with High Magnification Module
K182569 · Heidelberg Engineering GmbH · Oct 2018
Spectralis HRA + OCT and variants
K173648 · Heidelberg Engineering GmbH · Aug 2018
Avanti
K180660 · Optovue, Inc. · Jun 2018
P200TE
K173707 · Optos Plc. · Feb 2018