Cleared Special

K080681 - KOWA GENESIS-D

K080681 is an FDA 510(k) clearance for KOWA GENESIS-D, 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 25-day FDA review.

K080681 · Kowa Co. , Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
25d
Days
Class 2
Risk

K080681 is an FDA 510(k) clearance for the KOWA GENESIS-D. 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 April 4, 2008 after a review of 25 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 - K080681

510(k) Number K080681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2008
Decision Date April 04, 2008
Days to Decision 25 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
85d faster than avg
Panel avg: 110d · This submission: 25d
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 K080681.
KOWA NONMYD ALPHA-DIII
K082767 · Kowa Co. , Ltd. · Oct 2008
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CR-1
K080883 · Canon, Inc. · Apr 2008
ORION
K070231 · Nidek Technologies Srl · Apr 2007
CF-1
K063717 · Canon, Inc. · Jan 2007
RETINAL FUNCTIONAL IMAGER (RFI)
K062416 · Optical Imaging , Ltd. · Nov 2006