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510(k) Data Aggregation
K Number
K230549Device 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
Manufacturer
Date Cleared
2023-04-25
(56 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Xiazhifeng Electronic Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IPL Hair Removal Device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.
Device Description
The IPL Hair Removal Device is a personal, light-based, hair reduction device. The device provides hair reduction using IPL technology. Of which, 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-B509AG, 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.
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