Cleared Special

K130289 - TRC-NW8 NON-MYDRIATIC RETINAL CAMERA

K130289 is an FDA 510(k) clearance for TRC-NW8 NON-MYDRIATIC RETINAL CAMERA, manufactured by Topcon Corp.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Special 510(k) pathway after a 94-day FDA review.

K130289 · Topcon Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
94d
Days
Class 2
Risk

K130289 is an FDA 510(k) clearance for the TRC-NW8 NON-MYDRIATIC RETINAL CAMERA. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Topcon Corp. (North Reading, US). The FDA issued a Cleared decision on May 10, 2013 after a review of 94 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.

View all Topcon Corp. devices

FDA 510(k) Submission Details - K130289

510(k) Number K130289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2013
Decision Date May 10, 2013
Days to Decision 94 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 110d · This submission: 94d
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 61
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