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510(k) Data Aggregation
K Number
K221466Device Name
IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17
Manufacturer
Date Cleared
2022-08-12
(85 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Century Dongyuan Technology Co Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IPL Hair Removal Device (Model : AI01, AI06, AI08, AI16, AI17) is intended for the removal of unwanted body hair.
Device Description
IPL Hair Removal Device, models: Al01, Al06, Al08, Al16, Al17 are hand-held overthe-counter devices for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). The device is powered by an external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon arc flashlamp, a skin sensor to detect appropriate skin contact, and a skin color detection system to detect the skin color. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The skin color detection system detects whether a skin tone is suitable for treatment. If the skin tone is not in the range suitable for treatment, the device is designed to not emit the treatment light pulses. The light pulses are selectively absorbed by the hair follicles, which results in the hair follicles being temporarily heated. This results in a reduction of hair growth from the treated hair follicles.
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K Number
K212897Device Name
IPL Hair Removal Device, model: AI01
Manufacturer
Date Cleared
2021-11-04
(55 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Century Dongyuan Technology Co Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IPL Hair Removal Device (Model: AI01) is intended for the removal of unwanted body hair.
Device Description
IPL Hair Removal Device, model: Al01 is a device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface 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 contains a Xenon Arc Flashlamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. Device includes a main unit, an adaptor, and accessories, accessories include goggle.
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