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510(k) Data Aggregation
K Number
K243030Device Name
Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
Manufacturer
Ulike Co., Ltd.
Date Cleared
2024-10-25
(28 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Ulike Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the longterm, 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
Diamond Air+, Model: UI04A, UI04B, UI04C, UI04M, UI04G, UI04W is a light-based device for long-term hair removal. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology can achieve long-term hair removal results at a fraction of the energy level used in other light -based hair removal equipment.
The size of the device is about 60*38*169.86mm (W x D x H). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the Diamond Air+ is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
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