Cleared Traditional

K200254 - Mydriatic Hyperspectral Retinal Camera ...

K200254 is the FDA 510(k) clearance for Mydriatic Hyperspectral Retinal Camera ... by Optina Diagnostics. It is a Class 2 Ophthalmic device (product code HKI) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K200254 · Optina Diagnostics · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
84d
Days
Class 2
Risk

K200254 is an FDA 510(k) clearance for the Mydriatic Hyperspectral Retinal Camera (MHRC-C1). Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Optina Diagnostics (Montreal, CA). The FDA issued a Cleared decision on April 27, 2020 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - 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 Optina Diagnostics devices

Submission Details

510(k) Number K200254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2020
Decision Date April 27, 2020
Days to Decision 84 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
26d faster than avg
Panel avg: 110d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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

CardioMed Device Consultants, LLC
Elisa Harvey

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 - HKI Camera, Ophthalmic, Ac-powered

All 58
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