John Hiebert, M.D.John Hiebert, M.D., Kansas City, MO, Dec. 28, 1998 (CDRH-OC). An ad in the "Kansas City Star" for the DermaPeel Microdermabrasion Microdermabrasion (often referred to as Microderm) is a cosmetic procedure popular in day spas, doctors' practices, and medical spas, in which the stratum corneum (dead outermost surface of the skin) is partially or completely removed by light abrasion. device, manufactured by Derma Genesis, made claims not covered by the product's 510(k), FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. said. While the device was cleared for removing acne scars, tattoos, scar removal and general dermabrasion dermabrasion /derm·abra·sion/ (der?mah-bra´zhun) planing of the skin done by mechanical means, e.g., sandpaper, wire brushes, etc.; see planing. der·ma·bra·sion n. , the ad referenced removal of chickenpox chickenpox or varicella Contagious viral disease producing itchy blisters. It usually occurs in epidemics among young children, causes a low fever, and runs a mild course, leaving patients immune. The blisters can scar if scratched. scars, stretch marks, facial lines, wrinkles and age spots, all of which would require a new 510(k), according to the letter (See June 28 issue, page 1, for more background). |
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