Manufacturer
Shenzhen Bosidin Technology Co., Ltd.IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
Shenzhen Bosidin Technology Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Device details
FDA 510(k) registration fields
- K number
- K192432
- Device name
- IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-09-05
- Decision date
- 2019-11-08
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyFace
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Intended Use
IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Device Description
The IPL Home Use Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. 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. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only. The IPL Home Use Hair Removal Device includes D-1128, D-1103, D-1119, D-1129 and D-1130 five models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, LCD display contents, hair removal lamp cartridge's quantity and appearance, as well as lamp tube's placement location; in addition, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) is different; but these differences do not affect or change the intended use of the device.
Summary parsed at:2026-06-11 04:26:31 UTC
Predicate devices
3—
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Not ingested
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—
Not ingested
IPL Salon Hair Reduction System
Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt
K192432 references 3 predicate/reference devices
Cited as predicate
16IPL Hair removal
Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.
Superior Hair Remover
IPL Home Use Hair Removal Device
IPL Home Use Hair Removal Device
IPL Hair Removal Device
Leaf Smooth
IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
IPL HAIR REMOVAL HANDSET, Model: IPL-666
IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)
IPL hair removal
Diamond Air+ (UI04A, UI04B, UI04C)
IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32
IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002
IPL Hair Removal, Model: W-1095, W-1098
IPL Hair Removal Device (BE932C, BE932D, BE932E)
16 submissions cite K192432 as a predicate
