Manufacturer
Hunan Guangye Biotechnology Co., Ltd.IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439
Hunan Guangye Biotechnology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K222432
- Device name
- IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-08-12
- Decision date
- 2022-10-11
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyLegsBikini / BrazilianUnderarm
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
IPL Hair Removal Device is indicated for the 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.
Intended Use
IPL Hair Removal Device is indicated for the 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: KCA423, KCA437, KCA439), is an over-the-counter, home-use and single-person-use 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 only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas (such as: underarms, bikini lines, arms, legs, etc.). It contains a skin proximity sensor to detect appropriate skin contact; if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Models KCA437 and KCA439 have skin tone sensor to identify user's skin tone. Only users with suitable skin tone can use this device. IPL Hair Removal Device, model: KCA423, KCA437, KCA439 have the same indication for use, performance, structure design and operation; the only differences are appearance, capacitor and whether it's equipped with skin tone sensor (KCA437 and KCA439 have skin tone sensor while KCA423 does not).
Summary parsed at:2026-06-11 04:34:47 UTC
Predicate devices
2—
—
Not ingested
IPL Salon Hair Reduction System
Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt
K222432 references 2 predicate/reference devices
Cited as predicate
1Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
1 submission cite K222432 as a predicate
