Lasers for Temporary Increase of Clear Nail in Patients With Onychomycosis

What Is This Device?

For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).

How Is PDZ Classified?

Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis is FDA product code PDZ, Class 2, 21 CFR 878.4810.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2013. None was by a company in China. The root cause the FDA records most often is Labeling False and Misleading (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.