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Hand-held IPL device(JOVS Graphene Hair Removal Device)

Shenzhen Qianyu Technology Co., Ltd.

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

Product code OHT· 21 CFR 878.4810

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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
K214113
Device name
Hand-held IPL device(JOVS Graphene 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
2021-12-30
Decision date
2022-03-28
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
BodyFace
Primary application
Body
Classification source
AI classified

Indications for Use

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

Intended Use

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

Device Description

The Hand-held IPL device (JOVS Graphene Hair Removal Device) has the same intended use, mode of action and similar operational characteristics as the light-based over-the-counter hair removal devices.

Summary parsed at:2026-06-11 04:30:48 UTC

Predicate devices

2

K214113 references 2 predicate/reference devices

Cited as predicate

2

2 submissions cite K214113 as a predicate