Product code OHT· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Diamond Air+ (Model: UI04A, UI04B, UI04C) is a light-based device for long-term hair removal intended to be sold over-the-counter directly to the end user. The subject device is identical to that cleared via K213558. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device utilizes the IPL technology with 5 Levels of output energy. The size of the device is 60*38*169.86mm (W x D x H). It contains a Xenon Lamp and a skin contact sensor to detect appropriate skin application. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device will not start treatment.
Summary parsed at:2026-06-11 04:33:35 UTC
