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510(k) Data Aggregation
K Number
K242710Device Name
Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)
Date Cleared
2024-12-06
(88 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jianchao Intelligent Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Device Description
Hair Removal Device (Model: R3C16-P, R3C16-G; R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro), is an over-the-counter, home-use and personal device for hair reduction 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. Hair Removal Device includes two series (R3C16 series) with a total of 10 models. The two series products adopt identical intended use, similar performance and operation, consisting of IPL host and power adapter, which the host is mainly composed of lamp tube, filter, display screen, buttons, thermoelectric cooler, fan, and DC socket. The device is only powered by the external power adapter. The device is fitted with a skin sensor to detect appropriate skin contact, if the treatment window of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission is by manual finger switch or auto light emission. All models of the Hair Removal Device have a cooling function for a better hair removal experience, but the main difference is that the model with "Pro" in the model name is equipped with sapphire while the model without "Pro" uses metal treatment window surface.
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K Number
K232575Device Name
Hair Removal Device, Model(s): R2815-G Pro, R2815-G
Date Cleared
2023-11-20
(87 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jianchao Intelligent Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Device Description
Hair Removal Device (Model: R2815-G Pro, R2815-G), is an over-the-counter, home-use and personal device for hair reduction 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 Hair Removal Device includes two models that are R2815-G Pro, R2815-G, and their indications for use, work principle, product structure and composition, electrical structure, performance and operation are basically the same, the only difference is that the R2815-G Pro is equipped with sapphire while R2815-G is not but with a metal treatment window surface. The device is only powered by the external power adapter. The device is fitted with a skin sensor to detect appropriate skin contact, if the treatment window of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission activation is by finger switch.
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