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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 K052354
Device Name OCULASE MD
Applicant
BIOLASE TECHNOLOGY, INC.
981 CALLE AMANECER
SAN CLEMENTE,  CA  92673
Applicant Contact JEFFREY W JONES
Correspondent
BIOLASE TECHNOLOGY, INC.
981 CALLE AMANECER
SAN CLEMENTE,  CA  92673
Correspondent Contact JEFFREY W JONES
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/29/2005
Decision Date 07/05/2006
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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