Cleared Special

K062356 - KOWA NONMYD ALPHA-D

K062356 is an FDA 510(k) clearance for KOWA NONMYD ALPHA-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 44-day FDA review.

K062356 · Kowa Co. , Ltd. · Ophthalmic device
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Sep 2006
Decision
44d
Days
Class 2
Risk

K062356 is an FDA 510(k) clearance for the KOWA NONMYD ALPHA-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 September 27, 2006 after a review of 44 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.

View all Kowa Co. , Ltd. devices

FDA 510(k) Submission Details - K062356

510(k) Number K062356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2006
Decision Date September 27, 2006
Days to Decision 44 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
66d faster than avg
Panel avg: 110d · This submission: 44d
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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