Cleared Traditional

K190056 - KOWA VK-2s (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190056 · Kowa Co. Ltd. Chofu · Ophthalmic device
Feb 2019
Decision
32d
Days
Class 2
Risk

K190056 is an FDA 510(k) clearance for the KOWA VK-2s. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Kowa Co. Ltd. Chofu (Chofu City, JP). The FDA issued a Cleared decision on February 12, 2019 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 892.2050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K190056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2019
Decision Date February 12, 2019
Days to Decision 32 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 156d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFJ System, Image Management, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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.