NAD: Firm's Laser Cap Hair-Regrowth Claims Not Supported, Despite FDA Clearance

摘要

The Capillus82 Hair Regrowth Laser Cap may be "substantially equivalent" to the manufacturer's Capillus272 Pro device, based on FDA's 510(k) clearance, but NAD says hair-growth clinical findings from that "predicate" device cannot serve to substantiate claims for the untested Capillus82. The case illustrates complexities in the medical device segment, which increasingly is of interest to cosmetics companies.