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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 K071328
Device Name VISUALASE THERMAL THERAPY SYSTEM
Applicant
BIOTEX, INC.
8058 EL RIO ST.
HOUSTON,  TX  77054 -4185
Applicant Contact MATTHEW FOX
Correspondent
BIOTEX, INC.
8058 EL RIO ST.
HOUSTON,  TX  77054 -4185
Correspondent Contact MATTHEW FOX
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
FRN   LLZ  
Date Received05/11/2007
Decision Date 08/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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