Shenzhen Borria Technology Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
IPL hair removal machine is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
IPL hair removal machine is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
The BR2020 IPL hair removal machine 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 to perform hair removal. The device mainly consists of IPL main body and power adapter two parts and it is only powered by the external power adapter, as well as the treatment window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and its IPL emission activation is by finger switch. If the treatment window of the device is not properly applied to the treatment area, the device cannot be triggered a pulse.
Summary parsed at:2026-06-11 04:29:27 UTC
No later 510(k)s cite this device yet
Other submissions will appear here when they list K213020 as a predicate
