FDA Clearance

ChromaGen Vision, LLC acquired worldwide rights to distribute ChromaGen^® products in 2007 (excl. Europe) from Cantor & Nissel—an English firm—who secured the clearance to market ChromaGen, as granted by the United States Food and Drug Administration (FDA).

ChromaGen holds a 510(k) clearance granted by the FDA, for the following indications for use:

1. the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons
2. as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error
3. to enhance color discrimination in patients with protan or deutan color-vision deficiencies

510(k) Premarket Notification Explained

This type of FDA notification is described as: a clearance. An approval relates to the FDA's action on a premarket approval application—or "PMA". The primary distinction between a clearance and an approval is semantic. Simply put: 510(k) premarket notifications are cleared, while PMAs are approved.

A company that has received favorable action on its application may market the product for the claims in its labeling. The overwhelming majority of devices go through the 510(k) premarket clearance—not the PMA approval process.

For more information visit the United States Food & Drug Administration's website.