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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 K092197
Device Name PHOTEX30 DIODE LASER SERIES: 980, 810, 940
Applicant
BIOTEX, INC.
8058 EL RIO ST.
HOUSTON,  TX  77054 -4185
Applicant Contact ASHOK GOWDA
Correspondent
BIOTEX, INC.
8058 EL RIO ST.
HOUSTON,  TX  77054 -4185
Correspondent Contact ASHOK GOWDA
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/21/2009
Decision Date 10/06/2009
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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