Manufacturer
Shenzhen Bsx Technology Electronics Co., Ltd.IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
Shenzhen Bsx Technology Electronics 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
- K230097
- Device name
- IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-01-13
- Decision date
- 2023-04-06
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyFace
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Intended Use
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Device Description
IPL Hair Removal Device (Model: BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108), 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 only powered by the external power adapter (a.c.100~240V 50/60Hz) and its IPL emission activation is by finger switch. It contains a skin sensor to detect appropriate skin contact; if the Light Outlet of the device is not in full contact with the skin, the device cannot trigger a light pulse. The device has six models and these models share the same performance, structure and operation, the only difference is their enclosure color.
Summary parsed at:2026-06-11 04:38:17 UTC
Predicate devices
3IPL Salon Hair Reduction System
Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt
Leaf Smooth
IPL HAIR REMOVAL HANDSET, Model: IPL-666
K230097 references 3 predicate/reference devices
Cited as predicate
6IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)
IPL Cooling Hair Removal Device
Light Based Hair Removal Device
Intense Pulse Light Therapeutic Apparatus
IPL Hair Removal Device (JM-843, JM-865, JM-638)
IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29)
6 submissions cite K230097 as a predicate