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510(k) Data Aggregation
K Number
K213830Device Name
Home use hair removal device, model: Precise Touch Pro
Manufacturer
Date Cleared
2022-02-01
(55 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Iluminage Beauty Co., Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Home use hair removal device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Device Description
The Precise Touch Pro Home use hair removal device is a personal. light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology to perform hair removal. The device mainly consists of IPL main body, AC adapter and device stand three parts and it is only powered by the external power adapter, as well as the treatment window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and the built-in skin sensor to detect the body skin area. If the device is not properly applied to the expected treatment area (in full contact with the skin), the device cannot be automatic triggered a pulse emitting.
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