Shenzhen Beauty Every Moment Intelligent Electric 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 an over-the-counter device intended for removal of unwanted body and/or facial hair.
IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
The IPL Home Use Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting. The IPL Home Use Hair Removal Device includes D-1128, D-1129, D-1130, D-1119, D-1103, D-1176, D-1151, D-T1002 eight models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, display contents, lamp cartridge's quantity and appearance as well as the placement location of lamp tube; in additional, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) and output density is a little different; but these differences do not affect or change the intended use of the device.
Summary parsed at:2026-06-11 04:28:13 UTC
IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
K211922 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K211922 as a predicate
