IPL 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

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Product code

OHT
21 CFR 878.4810

Predicate devices

2

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

2

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0

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