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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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