IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130

Shenzhen Bosidin Technology Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code OHT· 21 CFR 878.4810

View Summary PDF

Product code

OHT
21 CFR 878.4810

Predicate devices

3

Cited as predicate

16

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

K192432 references 3 predicate/reference devices

Cited as predicate

16

16 submissions cite K192432 as a predicate