Cleared Special

K182569 - Spectralis HRA+OCT and variants with High Magnification Module (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K182569 · Heidelberg Engineering GmbH · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
30d
Days
Class 2
Risk

K182569 is an FDA 510(k) clearance for the Spectralis HRA+OCT and variants with High Magnification 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 October 18, 2018 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Heidelberg Engineering GmbH devices

Submission Details

510(k) Number K182569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2018
Decision Date October 18, 2018
Days to Decision 30 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 110d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 Peers - OBO Tomography, Optical Coherence

All 64
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