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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 K974536
Device Name PHOTODERM HR SYSTEM
Applicant
Esc Medical Systems , Ltd.
Yokneam Industrial Park
Yokneam,  IL 20692
Applicant Contact ZVI LADIN
Correspondent
Esc Medical Systems , Ltd.
Yokneam Industrial Park
Yokneam,  IL 20692
Correspondent Contact ZVI LADIN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/02/1997
Decision Date 05/20/1998
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
Predetermined Change
Control Plan Authorized		 No
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