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510(k) Data Aggregation
K Number
K210119Device Name
IPL Hair Removal Device (Model: KCA423)
Date Cleared
2021-05-21
(122 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IPL Hair Removal Device (Model: KCA423) indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. 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
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