Light, Ultraviolet, Dermatological

How Is FTC Classified?

Light, Ultraviolet, Dermatological is FDA product code FTC, Class 2, 21 CFR 878.4630.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 11 clearances under this code; the FDA took a median of 157 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 15 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Software Design Change (5), Labeling mix-ups (2) and Employee error (1).

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