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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 K982827
Device Name DERMA K ER:YAG/CO2 LASER
Applicant
Esc Medical Systems, Inc.
250 First Ave.
Suite 300
Needham,  MA  02494
Applicant Contact GEORGE J HATTUB
Correspondent
Esc Medical Systems, Inc.
250 First Ave.
Suite 300
Needham,  MA  02494
Correspondent Contact GEORGE J HATTUB
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/11/1998
Decision Date 09/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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