Manufacturer
Shenzhen Yuwei Electronic Technology Co., Ltd.IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
Shenzhen Yuwei Electronic Technology 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
- K220222
- Device name
- IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-01-26
- Decision date
- 2022-04-26
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyOther
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
Intended Use
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
Device Description
The IPL 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 to perform hair removal. The device mainly consists of IPL main body and power adapter two parts and it is only powered by the external power adapter, as well as the flash window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and its IPL emission activation is by finger switch. If the flash window of the device is not properly applied to the treatment area, the device cannot be triggered a pulse. There are six models in this application: S1-A, S2-A, S1, S2, S3, and S4. According to the declaration of the manufacturer, the difference of all models is mainly the exception of the product appearance, display contents on the display and the spot size of treatment window which does not affect the intended use. The spot size of model S1-A and S2-A is designed to 3.0cm2, model S1, S2, S3, and S4 is designed to 4.1cm2, as well as the energy density of the all models is in the range of 2.2~5.6J/cm2.
Summary parsed at:2026-06-11 04:30:59 UTC
Predicate devices
2IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.
K220222 references 2 predicate/reference devices
Cited as predicate
2Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)
2 submissions cite K220222 as a predicate