Cleared Traditional

VISTA DIGITAL OPTHALMOSCOPE (K102412) - FDA 510(k) Clearance

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

K102412 · Eyequick.Llc · Ophthalmic device
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Jun 2011
Decision
303d
Days
Class 2
Risk

K102412 is an FDA 510(k) clearance for the VISTA DIGITAL OPTHALMOSCOPE. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Eyequick.Llc (El Paso,Tx, US). The FDA issued a Cleared decision on June 23, 2011 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Eyequick.Llc devices

Submission Details

510(k) Number K102412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2010
Decision Date June 23, 2011
Days to Decision 303 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
193d slower than avg
Panel avg: 110d · This submission: 303d
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 155
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