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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 K984424
Device Name AURA DYE LASER SYSTEM (ADLS)
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 Received12/11/1998
Decision Date 03/05/1999
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
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