Cleared Traditional

K081858 - RETCAM 3 OPHTHALMIC IMAGING SYSTEM

K081858 is an FDA 510(k) clearance for RETCAM 3 OPHTHALMIC 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 127-day FDA review.

K081858 · Clarity Medical Systems · Ophthalmic device
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Nov 2008
Decision
127d
Days
Class 2
Risk

K081858 is an FDA 510(k) clearance for the RETCAM 3 OPHTHALMIC 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 November 5, 2008 after a review of 127 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 Clarity Medical Systems devices

FDA 510(k) Submission Details - K081858

510(k) Number K081858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2008
Decision Date November 05, 2008
Days to Decision 127 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
17d slower than avg
Panel avg: 110d · This submission: 127d
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 77
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K081858.
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K080883 · Canon, Inc. · Apr 2008
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K080681 · Kowa Co. , Ltd. · Apr 2008