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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K081656
Device Name VISUALASE THERMAL THERAPY SYSTEM
Applicant
BIOTEX, INC.
8058 EL RIO ST.
HOUSTON,  TX  77054 -4185
Applicant Contact ROGER MCNICHOLS
Correspondent
BIOTEX, INC.
8058 EL RIO ST.
HOUSTON,  TX  77054 -4185
Correspondent Contact ROGER MCNICHOLS
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
FRN   GEX  
Date Received06/12/2008
Decision Date 09/10/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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