Manufacturer
Shenzhen Qianyu Technology Co., Ltd.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
Product code
OHT
21 CFR 878.4810
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
3Hand-held IPL device(JOVS Graphene Hair Removal Device)
IPL HAIR REMOVAL HANDSET, Model: IPL-666
IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD
K231800 references 3 predicate/reference devices
Cited as predicate
1IPL 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)
1 submission cite K231800 as a predicate