Cleared Traditional

Spectralis HRA + OCT and variants (K173648) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173648 · Heidelberg Engineering GmbH · Ophthalmic device
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Aug 2018
Decision
276d
Days
Class 2
Risk

K173648 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 August 30, 2018 after a review of 276 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 K173648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2017
Decision Date August 30, 2018
Days to Decision 276 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
166d slower than avg
Panel avg: 110d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. 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.

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 K173648.
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Spectralis HRA+OCT and variants with OCT Angiography Module
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