Cleared Special

K083387 - MODIFICATION TO KOWA NONMYD ALPHA-DIII (FDA 510(k) Clearance)

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

K083387 · Kowa Co. , Ltd. · Ophthalmic device
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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.

View all Kowa Co. , Ltd. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 110d · This submission: 60d
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

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