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510(k) Data Aggregation
K Number
K070270Device Name
PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
Manufacturer
KIRCHNER & WILHELM GMBH + CO.KG
Date Cleared
2007-11-05
(280 days)
Product Code
HLJ
Regulation Number
886.1570Why did this record match?
Applicant Name (Manufacturer) :
**KIRCHNER **& WILHELM GMBH + CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.
Device Description
All Kirchner & Wilhelm ophthalmoscopes are battery powered. The Piccolight E50 and Eurolight E10 and E30 are single aperture ophthalmoscopes while the Piccolight E56 and Eurolight E36 have six apertures each. The Piccolight and Eurolight series are different in the handles, with Piccolight handles made of PA 6 GF 30% while Eurolight handles are made of metal. The Piccolight E50 and Eurolight E10 heads are same as the Eurolight E30 head except for the locking system. Similarly, but for the locking system, the Piccolight E56 and Eurolight E36 heads are the same.
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