Wuhan Lotuxs Technology Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
DermRays Revive is intended for hair removal, permanent hair reduction. Permanent hair reduction is 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. DermRays Revive is also intended for treatment of wrinkles. DermRays Revive is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
DermRays Revive is intended for hair removal, permanent hair reduction. Permanent hair reduction is 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. DermRays Revive is also intended for treatment of wrinkles. DermRays Revive is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
DermRays Revive uses a diode laser with an output wavelength of 1064nm, to act on the dermis through the epidermis, and the laser energy is absorbed by the target tissues (melanin, hemoglobin, and water). Due to the selective photothermal effect of the laser, it can treat wrinkles, without damaging the skin. Simultaneously, the laser can act on the melanin in the hair follicles, destroy hair follicles in the growth around the hair follicles, so as to remove hairs. The device consists of a power adapter, a power cord and a main unit.
Summary parsed at:2026-06-01 05:26:24 UTC
