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510(k) Data Aggregation
K Number
K221451Device Name
IPL hair removal
Manufacturer
Date Cleared
2022-08-01
(75 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Lizbella Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IPL hair removal is an over-the-counter device intended for removal of unwanted body hair.
Device Description
The IPL hair removal is a personal, light-based, hair reduction device intended to be sold overthe-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 IPL hair removal is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not in full contact with the skin, the device cannot emit the light pulse.
The IPL hair removal includes FZ-610, FZ-612, FZ-611, FZ-613, and FZ-608 six models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly contains product appearance and its spot size of the treatment window, but these differences do not affect or change the intended use of the device.
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