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510(k) Data Aggregation
K Number
K070287Device Name
PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
Manufacturer
Date Cleared
2007-02-12
(14 days)
Regulation Number
872.4630Why did this record match?
Product Code :
EBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AC-powered dental operating light, which can be attached via optical fibers to a surgical headlight, is a device intended to illuminate oral structures and operating areas.
Device Description
The cold light sources of the PS series consist of short arc metal-halide or xenon lamps, driven by electronic ballasts. Optical components such as mirrors, lenses, filters and coatings focus the light to a very small diameter of typically 1.5-3mm, Fiber light guides (single or bundles) transmit the light to the application such as headlights, endoscopes or other lighted tools.
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