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510(k) Data Aggregation
K Number
K073477Device Name
PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS
Manufacturer
PHOTONOVA OFSWEDEN AB
Date Cleared
2008-05-09
(150 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PHOTONOVA OFSWEDEN AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PhotoNova Family of Pulsed Light Systems is indicated for the following:
• The removal of unwanted hair form all skin types and to effect stable long-term or permanent hair reduction
• The treatment of benign pigmented lesions, including lentigines, nevi, melasma and café-au-lait
• The treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, ttelangiectasias, rosacea, facial and leg veins
• Treatment of inflammatory acne (acne vulgaris)
Device Description
The Photonova Pulsed Light Systems 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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