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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 K991628
Device Name MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA
Applicant
Esc Medical Systems, Inc.
Yokneam Industrial Park
P.O. Box 240
Yokneam,  IL 20692
Applicant Contact ZVI LADIN
Correspondent
Esc Medical Systems, Inc.
Yokneam Industrial Park
P.O. Box 240
Yokneam,  IL 20692
Correspondent Contact ZVI LADIN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/11/1999
Decision Date 08/09/1999
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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