Cleared Traditional

K102859 - RETCAM 3 OPTHALMIC IMAGING SYSTEM

K102859 is an FDA 510(k) clearance for RETCAM 3 OPTHALMIC IMAGING SYSTEM, manufactured by Clarity Medical Systems. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K102859 · Clarity Medical Systems · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
202d
Days
Class 2
Risk

K102859 is an FDA 510(k) clearance for the RETCAM 3 OPTHALMIC IMAGING SYSTEM. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Clarity Medical Systems (Pleasanton, US). The FDA issued a Cleared decision on April 20, 2011 after a review of 202 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K102859

510(k) Number K102859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2010
Decision Date April 20, 2011
Days to Decision 202 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
92d slower than avg
Panel avg: 110d · This submission: 202d
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 K102859.
DIGITAL RETINAL CAMERA
K111612 · Canon, Inc. · Sep 2011
VISTA DIGITAL OPTHALMOSCOPE
K102412 · Eyequick.Llc · Jun 2011
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
K110986 · Optomed OY · May 2011
KOWA NONMYD WX
K101628 · Kowa Co. , Ltd. · Jan 2011
ISCREEN VISION SCREENER
K102651 · Iscreen Vision, Inc. · Jan 2011
TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM
K101861 · Truevision Systems, Incorporated · Dec 2010
K102859 · RETCAM 3 OPTHALMIC IMAGING SYSTEM
Download PDF FDA Summary Clarity Medical Syste…