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510(k) Data Aggregation
K Number
K240093Device Name
IPL Home Use Hair Removal Device (SJ15)
Manufacturer
Date Cleared
2024-04-24
(103 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Shuge Medical Beauty Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IPL Home Use 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 Home Use Hair Removal Device (Model:515) is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL)to emit a specific wavelength of the light ranging from 550-1200m and delivers to the skin. The device is designed to help break the cycle of hair re-growth. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy (below the surface of the surface of the skin), which disables the har follicle preventing further growth, so as to achieve effective hair removal.
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