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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mini Endoscope, Gastroenterology-Urology
510(k) Number K091962
Device Name POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200
Applicant
Lumenis, Inc.
5302 Betsy Ross Rd.,
Santa Clara,  CA  95054
Applicant Contact MIKE AYMAMI
Correspondent
Lumenis, Inc.
5302 Betsy Ross Rd.,
Santa Clara,  CA  95054
Correspondent Contact MIKE AYMAMI
Regulation Number876.1500
Classification Product Code
ODF  
Date Received07/01/2009
Decision Date 09/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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