Shenzhen Century Dongyuan Technology CO , Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The IPL Hair Removal Device (Model: AI01, AI06, AI08, AI16, AI17) is intended for the removal of unwanted body hair. The IPL Hair Removal Device (Model: AI01) is intended for the removal of unwanted body hair. Over-The-Counter Use. Prescription Use. Patient Population: Adult.
The IPL Hair Removal Device (Model: AI01, AI06, AI08, AI16, AI17) is intended for the removal of unwanted body hair.
IPL Hair Removal Device, models: AI01, AI06, AI08, AI16, AI17 are hand-held over-the-counter devices for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). The device is powered by an external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon arc flashlamp, a skin sensor to detect appropriate skin contact, and a skin color detection system to detect the skin color. 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 skin color detection system detects whether a skin tone is suitable for treatment. If the skin tone is not in the range suitable for treatment, the device is designed to not emit the treatment light pulses. The light pulses are selectively absorbed by the hair follicles, which results in the hair follicles being temporarily heated. This results in a reduction of hair growth from the treated hair follicles.
Summary parsed at:2026-06-11 04:33:20 UTC
IPL Hair Removal Device, model: AI01
K221466 references 1 predicate/reference device
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