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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 K003705
Device Name XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
Applicant
PHOTO MEDEX, INC.
2431 IMPALA DR.
carlsbad,  CA  92008 -7227
Applicant Contact al memmolo
Correspondent
PHOTO MEDEX, INC.
2431 IMPALA DR.
carlsbad,  CA  92008 -7227
Correspondent Contact al memmolo
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/01/2000
Decision Date 03/01/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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