Manufacturer
Shenzhen Weikai Technology Co.,LtdIPL Hair removal
Shenzhen Weikai 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
- K203510
- Device name
- IPL Hair removal
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-11-30
- Decision date
- 2021-02-26
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyFace
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
IPL Hair removal is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Intended Use
IPL Hair removal is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Device Description
The IPL Hair removal 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. The device consists of IPL main body and power adapter two parts, and treatment window located in the main body which is the source of optical radiation, namely a Xenon Arc flashlamp; and the device is powered from power adapter via an external power. The IPL Hair removal includes V501, V201, V301-s, and V401 four models. Their intended use, performance, circuit principle, structure design and operation are basically identical, with the differences containing the appearance of the product, the size of PCB board and LCD display contents; and these differences do not affect or change the intended use of the device.
Summary parsed at:2026-06-11 04:26:54 UTC
Predicate devices
3—
—
Not ingested
—
—
Not ingested
IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
K203510 references 3 predicate/reference devices
Cited as predicate
2IPL hair removal machine
Home use hair removal device, model: Precise Touch Pro
2 submissions cite K203510 as a predicate