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
NCT02783807
Completed
Interventional
Industry-sponsored
Clinical Equivalency Validation Protocol Clinical Equivalency Eyenez Retina Camera v200 and Optomed Smartscope M5 EY3
Clinical Equivalency Validation Protocol Eyenez v200 and Volk Pictor Ret1
| Condition studied |
Diabetes |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Mark Kislinger, PhD MD |
| Sponsor |
Eyenez LLC
(industry)
|
Started 2015-10-01
→
Primary completion 2016-03-01
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Completed 2016-05-01
Primary outcome
Clinical Evaluation of Retina Camera Images from both Healthy and Diseased Subjects
Study completed - no results published.
This trial concluded in 2016 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510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov