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510(k) Data Aggregation
K Number
K232183Device Name
IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10
Manufacturer
Date Cleared
2023-09-22
(60 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Koli Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Device Description
IPL Hair Removal Device (Models:T1, T2, T3, T7, T10),is an over-the-counter, home-use and singleperson-use device for hair reduction by using 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 device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas. There are four function modes including skin, face,body and bikini for T1 and T7, but only body mode for T3, and five modes including skin, face,underarm,body and bikini for T2 and T10. There are five levels for each mode. The device contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses.
IPL Hair Removal Device, models:T1, T2, T3, T7, T10 have the same indication for use, performance, structure design and operation. The main difference mainly contains product appearance, dimension , weight , number of keys and function modes, spot size and energy density . The five models are in two colors, one set is in white and the other set is in green.
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