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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 K082721
Device Name LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS
Original Applicant
PHOTOMEDEX, INC.
147 keystone dr.
montgomeryville,  PA  18936
Original Contact alfred intintoli
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/17/2008
Decision Date 10/28/2008
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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