Cleared Special

K102013 - DIGITAL RETINAL CAMERA (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K102013 · Canon Inc. -Medical Equipment Group · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
105d
Days
Class 2
Risk

K102013 is an FDA 510(k) clearance for the DIGITAL RETINAL CAMERA. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Canon Inc. -Medical Equipment Group (Tachikawa-Shi, Tokyo, JP). The FDA issued a Cleared decision on October 29, 2010 after a review of 105 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 Canon Inc. -Medical Equipment Group devices

Submission Details

510(k) Number K102013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2010
Decision Date October 29, 2010
Days to Decision 105 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
5d faster than avg
Panel avg: 110d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

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 155
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K102013.
Eyer 2
K251353 · Phelcom Technologies · Jan 2026
Fundus On Phone Non Mydriatic (FOP NM-10)
K252120 · Remidio Innovative Solutions Private Limited · Dec 2025
Optina-4C (MHRC-C1N)
K250770 · Optina Diagnostics, Inc. · Sep 2025
3nethra neo HD FA
K243600 · Forus Health Pvt.Ltd · Aug 2025
Resolve Fundus Camera
K250683 · Optain Health, Inc. · Apr 2025
Sentinel Camera
K243664 · Ai Optics · Dec 2024