IPL Hair removal

Shenzhen Weikai Technology Co.,Ltd

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

Product code OHT· 21 CFR 878.4810

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Product code

OHT
21 CFR 878.4810

Predicate devices

3

Cited as predicate

2

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

K203510 references 3 predicate/reference devices

Cited as predicate

2

2 submissions cite K203510 as a predicate