Cleared Traditional

K062021 - KOWA VX-10I

K062021 is an FDA 510(k) clearance for KOWA VX-10I, manufactured by Kowa Co. , Ltd.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K062021 · Kowa Co. , Ltd. · Ophthalmic device
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Nov 2006
Decision
107d
Days
Class 2
Risk

K062021 is an FDA 510(k) clearance for the KOWA VX-10I. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Kowa Co. , Ltd. (Rockville, US). The FDA issued a Cleared decision on November 1, 2006 after a review of 107 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K062021

510(k) Number K062021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2006
Decision Date November 01, 2006
Days to Decision 107 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 110d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K062021.
ORION
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