Cleared Traditional

K102412 - VISTA DIGITAL OPTHALMOSCOPE

K102412 is an FDA 510(k) clearance for VISTA DIGITAL OPTHALMOSCOPE, manufactured by Eyequick.Llc. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K102412 · Eyequick.Llc · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K102412

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
Combination Product No
PCCP Authorized No
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.

HKI Device Classification - Class 2, Special Controls

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 153
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K102412.
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RETCAM 3 OPTHALMIC IMAGING SYSTEM
K102859 · Clarity Medical Systems · Apr 2011
KOWA NONMYD WX
K101628 · Kowa Co. , Ltd. · Jan 2011
K102412 · VISTA DIGITAL OPTHALMOSCOPE
Download PDF FDA Summary Eyequick.Llc