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510(k) Data Aggregation
K Number
K032191Device Name
OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM
Manufacturer
LUXSANO AB
Date Cleared
2003-08-20
(34 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LUXSANO AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OmniLight FPL System is intended to be used in the following procedures:
1. Hair Removal in all Skin types according to the Fitzpatrick Scale
2. Permanent Hair reduction
3. Treatment of Vascular Lesions
4. Treatment of Pigmented Lesion
5. Tattoo Removal
Device Description
The OmniLight Fluorescent Pulsed Light System delivers pulsed light at wavelengths starting at 515 nanometers. The device consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide
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