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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 K010834
Device Name LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
Applicant
LASERSCOPE
3052 ORCHARD DR.
SAN JOSE,  CA  95134 -2011
Applicant Contact PAUL H HARDIMAN
Correspondent
LASERSCOPE
3052 ORCHARD DR.
SAN JOSE,  CA  95134 -2011
Correspondent Contact PAUL H HARDIMAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/20/2001
Decision Date 05/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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