Manufacturer
Dongguan Boyuan Intelligent Technology Co.,LtdIPL Hair Removal Device (KCA511/KCA516/KCA522)
Dongguan Boyuan Intelligent Technology Co.,Ltd
Country / Region:China (CN)Submission type:Traditional
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
- K250253
- Device name
- IPL Hair Removal Device (KCA511/KCA516/KCA522)
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-01-28
- Decision date
- 2025-05-06
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- UnderarmBikini / BrazilianArmsLegs
- Primary application
- Underarm
- Classification source
- AI classified
Indications for Use
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. Applicable skin Fitzpatrick Skin Types I-V. Treatment area includes body parts such as underarm, bikini line, arms, facial hair below the chin line, back and legs.
Intended Use
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Device Description
IPL Hair Removal Device (Model: KCA511, KCA516, KCA522) is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is powered by an external power adapter and its IPL emission activation is by finger switch. This product adopts an irreplaceable treatment window and the spot size is 3.3cm² that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact; if the device is not in full contact with the skin, it cannot emit the treatment light pulses. Additionally, the device has a cooling function that will be activated throughout the hair removal process to provide users with a more comfortable experience. The IPL Hair Removal Device is used for removing excess facial hair and body hair and can also reduce hair regrowth. It can be used on body parts such as underarm, bikini line, arms, facial hair below the chin line, back, and legs.
Summary parsed at:2026-06-11 04:28:08 UTC
Predicate devices
2IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)
K250253 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K250253 as a predicate
