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510(k) Data Aggregation
K Number
K013511Device Name
XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)
Manufacturer
Date Cleared
2002-02-01
(102 days)
Product Code
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
ACULUX, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The XenaLight™ Fiberoptic Illuminator, also known as a lightsource, is attached to a fiberoptic cable transmitting the light to a fiberoptic headlamp, retractor, endoscopic instrument, etc, providing light to the surgical operating field. This light is utilized in many different surgical procedures requiring additional light when overhead lighting is not sufficient.
Device Description
The XenaLight™ Fiberoptic Illuminator, also known as a lightsource, is attached to a fiberoptic cable transmitting the light to a fiberoptic headlamp, retractor, endoscopic instrument, etc, providing light to the surgical operating field. This light is utilized in many different surgical procedures requiring additional light when overhead lighting is not sufficient.
The fiberoptic cable and/or headlamps are an accessory to the XenaLight™ Fiberoptic Illuminator to transmit the light from the lightsource.
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K Number
K001223Device Name
ACULUX, MODEL AX3001, AX3002
Manufacturer
Date Cleared
2000-06-23
(67 days)
Product Code
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
ACULUX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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