Manufacturer
Shenzhen Qianyu Technology Co., Ltd.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
Product code
OHT
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K214113
- Device name
- Hand-held IPL device(JOVS Graphene Hair Removal Device)
- 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—
—
Not ingested
IPL Hair Removal Device
K214113 references 2 predicate/reference devices
Cited as predicate
2Hand-held IPL device (JOVS Hair Removal Device)
IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
2 submissions cite K214113 as a predicate