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510(k) Data Aggregation
K Number
K240016Device Name
IPL Hair Removal Device (YT01,YT02,YT03,YT04)
Manufacturer
Shenzhen Jianrong Biomedical Electronics Co., Ltd
Date Cleared
2024-07-10
(190 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jianrong Biomedical Electronics Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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:YT01, YT02, YT04) 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 550-1200nm and delivers to the skin. The device is designed to help break the cycle of hair re-growth. 550 filter is applied in models YT01&YT02, 600 filter is applied in model YT03 and 640 filter is applied in model YT04.
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