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510(k) Data Aggregation
K Number
K073300Device Name
MILESMAN PREMIUM
Manufacturer
MILESMAN S.L.
Date Cleared
2007-12-04
(11 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MILESMAN S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Milesman Premium Pulsed Diode Array Laser System is intended for use in general and plastic surgery and dermatology procedures for the treatment of vascular lesions, such as angiomas, hemangiomas, telangiectasia and other benign vascular lesions and treatment for pseudofolliculitis barbae.
The Milesman Premium is also used for removal of unwanted hair, permanent hair reduction and the treatment of benign pigmented lesions and leg veins in all skin types (Fitzpatrick I-VI), including tanned skin.
Device Description
The Milseman Premium Pulsed Diode Array Laser System delivers pulsed laser light at 800 nm wavelength. The device consists of three interconnected sections: the system console, the handle hose (umbilical cord) to the handpiece, and the handpiece. The laser pulsed energy is delivered through the handpiece. A user is able to select specific laser parameters from the touch screen on top of the console.
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