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510(k) Data Aggregation
K Number
K250171Device Name
IPL Hair Removal Device (BE965A, BE965B, BE965C)
Manufacturer
Date Cleared
2025-03-19
(57 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Yang Wo 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
IPL Hair Removal Device is an over-the-counter, light based device for unwanted hair removal by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any culling, removing hair growth with minimal pain.
The device includes three models with the only difference in enclosure color. It is only power adapter and its PL emission activation is by a switch or auto light emission, and it contains a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. The device has a sapplire cooling function for a better hair removal experience.
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K Number
K241834Device Name
IPL Hair Removal Device (BE932C, BE932D, BE932E)
Manufacturer
Date Cleared
2024-09-23
(90 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Yang Wo 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 hand-held device that utilizes Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device includes three models with the only difference in enclosure color. It is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. The device has a cooling function for a better hair remove experience.
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Ask a specific question about this device
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