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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 K990718
Device Name ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
Applicant
Laserscope
3052 Orchard Dr.
San Jose,  CA  95134
Applicant Contact PAUL H HARDIMAN
Correspondent
Laserscope
3052 Orchard Dr.
San Jose,  CA  95134
Correspondent Contact PAUL H HARDIMAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/04/1999
Decision Date 03/08/2000
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
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