Manufacturer
Shenzhen Xiazhifeng Electronic Co., Ltd.IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG
Shenzhen Xiazhifeng Electronic Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K230549
- Device name
- IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-02-28
- Decision date
- 2023-04-25
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- FaceBodyLegsUnderarm
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The IPL Hair Removal Device is an over-the-counter device, intended for removal of unwanted body and/or facial hair. The Home use hair removal device is intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.
Intended Use
The IPL Hair Removal Device is an over-the-counter device, intended for removal of unwanted body and/or facial hair. The Home use hair removal device is intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.
Device Description
The IPL Hair Removal Device is a personal, light-based, hair reduction device. The device provides hair reduction using IPL technology. The Device includes FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG sixteen models. All have adopted the same structure design, consisting of IPL Hair Removal Device main unit and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from power adapter via an external power. The difference of all models is mainly appearance, cooling function and enclosure color, letter A in the model name means with skin cooling function, letter B means without skin cooling function, letter L means the enclosure color is light green, letter G is deep green, which do not affect the intended use.
Summary parsed at:2026-06-11 04:39:28 UTC
Predicate devices
2Home use hair removal device
IPL HAIR REMOVAL HANDSET, Model: IPL-666
K230549 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K230549 as a predicate
