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510(k) Data Aggregation
K Number
K232056Device Name
IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002
Manufacturer
Date Cleared
2023-10-06
(87 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Lide Electric Appliance 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 (Model: PB1, PB2, PB3, PB4, TM002), is an over-the-counter, homeuse 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 indications for use, performance, structure design and operation of these five models of the device are basically the same, there is only a minor difference in appearance and physical dimension. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product is equipped with a skin sensor to detect appropriate skin contact, if the flash window of the device is not in full contact with the skin, the device cannot emit the treatment light pulses.
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