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510(k) Data Aggregation
K Number
K230360Device Name
IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02
Manufacturer
Shenzhen Jizhimei Technology Co., Ltd.
Date Cleared
2023-04-10
(59 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jizhimei Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Device Description
IPL Cooling Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed two models with the same IPL technology for hair removal, which is model NBB01 and NBB02. The device 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 IPL Cooling Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.6cm2 that is suttable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc. The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Cooling Hair Removal Device has the cooling function, which will be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.
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