Cleared Special

K083387 - MODIFICATION TO KOWA NONMYD ALPHA-DIII

K083387 is an FDA 510(k) clearance for MODIFICATION TO KOWA NONMYD ALPHA-DIII, manufactured by Kowa Co. , Ltd.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Special 510(k) pathway after a 60-day FDA review.

K083387 · Kowa Co. , Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
60d
Days
Class 2
Risk

K083387 is an FDA 510(k) clearance for the MODIFICATION TO KOWA NONMYD ALPHA-DIII. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Kowa Co. , Ltd. (Chuo-Ku, Tokyo, JP). The FDA issued a Cleared decision on January 16, 2009 after a review of 60 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K083387

510(k) Number K083387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2008
Decision Date January 16, 2009
Days to Decision 60 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 110d · This submission: 60d
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 146
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K083387.
STATIC VESSEL ANALYZER
K082196 · Imedos GmbH · Jun 2009
DIGITAL RETINAL CAMERA, CR-1 MARK II
K090466 · Canon, Inc. · Mar 2009
RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP
K083771 · Clarity Medical Systems · Jan 2009
RETCAM 3 OPHTHALMIC IMAGING SYSTEM
K081858 · Clarity Medical Systems · Nov 2008
KOWA NONMYD ALPHA-DIII
K082767 · Kowa Co. , Ltd. · Oct 2008
MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)
K080180 · Optical Imaging , Ltd. · Jun 2008