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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K092735
Device Name GREENLIGHT XPS LASER SYSTEM
Applicant
American Medical Systems, Inc.
155-A Moffett Park Dr.,
Suite 210
Sunnyvale,  CA  94089
Applicant Contact DARLENE-CROCKET BILLIG
Correspondent
American Medical Systems, Inc.
155-A Moffett Park Dr.,
Suite 210
Sunnyvale,  CA  94089
Correspondent Contact DARLENE-CROCKET BILLIG
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/04/2009
Decision Date 11/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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