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Hand-held IPL device (JOVS Hair Removal Device)

Shenzhen Qianyu Technology Co., Ltd.

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

Product code OHT· 21 CFR 878.4810

Summary PDF

Company

Shenzhen Qianyu Technology Co., Ltd.
China (CN)

Product code

OHT
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

2
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Device details

FDA 510(k) registration fields

K number
K220645
Device name
Hand-held IPL device (JOVS Hair Removal Device)
Company
Shenzhen Qianyu Technology Co., Ltd.
Country / Region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-03-04
Decision date
2022-04-27
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
FaceBodyOther
Primary application
Other
Classification source
AI classified

Indications for Use

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

Intended Use

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

Device Description

Hand-held IPL device (JOVS Hair Removal Device) is a personal, light-based, hair reduction device. The device contains a Xenon lamp and provides hair reduction by Intense Pulsed Light (IPL) technology and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device is for single-person use only. Hand-held IPL device (JOVS Hair Removal Device) includes JR5C-E, JR5C-W, JR5C-OG, JR5-E, JR5-W, JR5-OG. Their intended use, performance, structure design and operation are basically identical, with the different color appearance.

Summary parsed at:2026-06-11 04:31:34 UTC

Predicate devices

2

K220645 references 2 predicate/reference devices

Cited as predicate

2

2 submissions cite K220645 as a predicate