Manufacturer
Shenzhen Yang WO Electronic Co., Ltd.IPL Hair Removal Device (BE932C, BE932D, BE932E)
Shenzhen Yang WO Electronic 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
- K241834
- Device name
- IPL Hair Removal Device (BE932C, BE932D, BE932E)
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-06-25
- Decision date
- 2024-09-23
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- FaceBodyOther
- Primary application
- Other
- 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 is an over-the-counter, light based device for unwanted hair reduction by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device includes three models with the only difference in enclosure color. It is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission, and it contains a skin sensor to detect appropriate skin contact; if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. The device has a cooling function for a better hair removal experience.
Summary parsed at:2026-06-11 04:46:50 UTC
Predicate devices
3IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
Hand-held IPL device (JOVS Hair Removal Device)
IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
K241834 references 3 predicate/reference devices
Cited as predicate
1IPL Hair Removal Device (BE965A, BE965B, BE965C)
1 submission cite K241834 as a predicate