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510(k) Data Aggregation
K Number
K992540Device Name
XENON LIGHT SOURCE PES 1
Manufacturer
Date Cleared
1999-09-14
(47 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
**LASER OPTIK SYSTEME GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The indication for use of the Xenon Light Source PES 1 is to provide illumination for fiberoptic endoscopy to gastroenterological, urological, gynecological and ENT cavities, hollow organs and canals. The PES 1 replaces current equipment in this branch. Operation is only allowed in medically used rooms in which the electrical installation meets the safety requirements of national standards (e.g. VDE 0107). The device is not intended for direct application at the heard or central nerve system.
Device Description
Xenon Light Source PES 1
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K Number
K953419Device Name
LOS 3D VISION 100
Manufacturer
Date Cleared
1996-02-08
(220 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
**LASER OPTIK SYSTEME GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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