IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9

Shenzhen Qianyu 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

1

Device details

FDA 510(k) registration fields

K number
K231800
Device name
IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-06-20
Decision date
2023-09-07
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
BodyFace
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 and/or facial hair.

Intended Use

IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Device Description

IPL Hair Removal Device is a personal, light-based, home-use hair reduction device intended to be sold over-the-counter. The device provides hair reduction by 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 (100-240V, 50/60Hz) and its IPL emission activation is by finger switch. It contains a skin sensor to detect appropriate skin contact; if the light outlet of the device is not in full contact with the skin, the device cannot emit the treatment light pulses. The device includes JP1, JR3, JR8, JR9 four models. There is difference in product appearance, physical product dimension, indicator display, spot size and output energy, but their intended use, performance, structure design and operation are basically identical.

Summary parsed at:2026-06-11 04:40:48 UTC

Predicate devices

3

K231800 references 3 predicate/reference devices

Cited as predicate

1
  • K251914

    IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002)

    Miley Technology (Hebei) Co., Ltd.

1 submission cite K231800 as a predicate