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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
Original Applicant
BIOTEX, INC.
8058 el rio st.
houston,  TX  77054 -4185
Original 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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