Cleared Special

K102651 - ISCREEN VISION SCREENER

K102651 is an FDA 510(k) clearance for ISCREEN VISION SCREENER, manufactured by Iscreen Vision, Inc.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Special 510(k) pathway after a 120-day FDA review.

K102651 · Iscreen Vision, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
120d
Days
Class 2
Risk

K102651 is an FDA 510(k) clearance for the ISCREEN VISION SCREENER. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Iscreen Vision, Inc. (Cordova, US). The FDA issued a Cleared decision on January 12, 2011 after a review of 120 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K102651

510(k) Number K102651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2010
Decision Date January 12, 2011
Days to Decision 120 days
Submission Type Special
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
10d slower than avg
Panel avg: 110d · This submission: 120d
Pathway characteristics
Modification to existing cleared device.

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
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K102651 · ISCREEN VISION SCREENER
Download PDF FDA Summary Iscreen Vision, Inc.