Guangzhou Haoxingwan Technology Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Superior Hair Remover is an over-the-counter device intended for removal of unwanted body and/or facial hair.
The Superior Hair Remover is an over-the-counter device intended for removal of unwanted body and/or facial hair.
The Superior Hair Remover, an over-the-counter device, is a home-use device for the removal of unwanted hair from body parts. The device provides hair reduction using Intense Pulse 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 can detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device can flash for 300,000 times. The device is composed of a hand-held handle, a main unit, an external power cord, and eye protector, two attachable flash heads. It is used AC Powered (100-240V AC, 50/60Hz). The Superior Hair Remover includes T31 and T61 two models. Their indications for use, working principle, mode of action, operating mode, over-temperature protection function, structure design, button function, skin contact detection function, treatment area, spot size and operation are basically identical, with the minor differences contains product appearance, control buttons on touch panel, light intensity levels.
Summary parsed at:2026-06-11 04:27:28 UTC
IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
K210376 references 1 predicate/reference device
No later 510(k)s cite this device yet
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