Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Home use hair removal device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
The Home use hair removal device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
The Precise Touch Pro 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 to perform hair removal. The device mainly consists of IPL main body, AC adapter and device stand three 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 the built-in skin sensor to detect the body skin area. If the device is not properly applied to the expected treatment area (in full contact with the skin), the device cannot be automatic triggered a pulse emitting.
Summary parsed at:2026-06-11 04:30:35 UTC
