Cleared Traditional

K161727 - Eyenez Ophthalmic Camera

K161727 is the FDA 510(k) clearance for Eyenez Ophthalmic Camera by Eyenez, LLC. It is a Class 2 Ophthalmic device (product code HKI) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K161727 · Eyenez, LLC · Ophthalmic device
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Oct 2016
Decision
104d
Days
Class 2
Risk

K161727 is an FDA 510(k) clearance for the Eyenez Ophthalmic Camera. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Eyenez, LLC (Pasadena, US). The FDA issued a Cleared decision on October 4, 2016 after a review of 104 days - within the typical 510(k) review window.

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: 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 Eyenez, LLC devices

Submission Details

510(k) Number K161727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2016
Decision Date October 04, 2016
Days to Decision 104 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 110d · This submission: 104d
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 Peers - HKI Camera, Ophthalmic, Ac-powered

All 59
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K161727.
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K090466 · Canon, Inc. · Mar 2009