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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Source, Endoscope, Xenon Arc
510(k) Number K992540
Device Name XENON LIGHT SOURCE PES 1
Applicant
Laser Optik Systeme GmbH & Co. KG
Am Sagewerk 11,6500 Mainz 23
Amtsgericht Mainz Hrb 4527
Germany,  DE
Applicant Contact R. HAPPERSBERGER
Correspondent
Laser Optik Systeme GmbH & Co. KG
Am Sagewerk 11,6500 Mainz 23
Amtsgericht Mainz Hrb 4527
Germany,  DE
Correspondent Contact R. HAPPERSBERGER
Regulation Number876.1500
Classification Product Code
GCT  
Date Received07/29/1999
Decision Date 09/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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