Shenzhen Shuge Medical Beauty Devices Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
IPL Home Use Hair Removal Device is indicated for the removal of unwanted 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.
IPL Home Use Hair Removal Device is indicated for the removal of unwanted 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.
IPL Home Use Hair Removal Device (Model:SJ15) is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL) to emit a specific wavelength of the light ranging from 550-1200nm and delivers to the skin. The device is designed to help break the cycle of hair re-growth. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy (below the surface of the skin), which disables the hair follicle preventing further growth, so as to achieve effective hair removal.
Summary parsed at:2026-06-11 04:44:08 UTC
No later 510(k)s cite this device yet
Other submissions will appear here when they list K240093 as a predicate
