Cleared Traditional

K123460 - TRC-NW300 NON-MYDRIATIC RETINAL CAMERA

K123460 is the FDA 510(k) clearance for TRC-NW300 NON-MYDRIATIC RETINAL CAMERA by Topcon Medical Systems, Inc.. It is a Class 2 Ophthalmic device (product code HKI) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K123460 · Topcon Medical Systems, Inc. · Ophthalmic device
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Feb 2013
Decision
89d
Days
Class 2
Risk

K123460 is an FDA 510(k) clearance for the TRC-NW300 NON-MYDRIATIC RETINAL CAMERA. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Topcon Medical Systems, Inc. (Oakland, US). The FDA issued a Cleared decision on February 6, 2013 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Topcon Medical Systems, Inc. devices

Submission Details

510(k) Number K123460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2012
Decision Date February 06, 2013
Days to Decision 89 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
21d faster than avg
Panel avg: 110d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 59
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