Manufacturer
Shenzhen Century Dongyuan Technology CO , Ltd.IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17
Shenzhen Century Dongyuan Technology CO , Ltd.
Country / Region:China (CN)Submission type:Special
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K221466
- Device name
- IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-05-19
- Decision date
- 2022-08-12
- Submission type
- Special
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyOther
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
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.
Intended Use
The IPL Hair Removal Device (Model: AI01, AI06, AI08, AI16, AI17) is intended for the removal of unwanted body hair.
Device Description
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
Predicate devices
1IPL Hair Removal Device, model: AI01
K221466 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K221466 as a predicate
