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510(k) Data Aggregation
K Number
K232846Device Name
Light Based Hair Removal Device
Manufacturer
Date Cleared
2023-12-07
(84 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen MEIK Beauty Industry Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Light Based Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
Device Description
The Light Based Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The Light Based Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse.
There are A113, A112, and AM001 three models in this application. Their work principle, function, intended use, structure, and composition are the same, with differences being product appearance, size, and energy output density are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.
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