Cleared Traditional

K090115 - RETINA CAMERA TRC-NW7SF MARK II

K090115 is an FDA 510(k) clearance for RETINA CAMERA TRC-NW7SF MARK II, manufactured by Topcon Corp.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K090115 · Topcon Corp. · Ophthalmic device
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Jun 2009
Decision
160d
Days
Class 2
Risk

K090115 is an FDA 510(k) clearance for the RETINA CAMERA TRC-NW7SF MARK II. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Topcon Corp. (Tokyo, JP). The FDA issued a Cleared decision on June 30, 2009 after a review of 160 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.

View all Topcon Corp. devices

FDA 510(k) Submission Details - K090115

510(k) Number K090115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date June 30, 2009
Days to Decision 160 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 110d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 61
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K090115.
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DIGITAL RETINAL CAMERA, CR-1 MARK II
K090466 · Canon, Inc. · Mar 2009
CR-1
K080883 · Canon, Inc. · Apr 2008
CF-1
K063717 · Canon, Inc. · Jan 2007