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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 K980187
Device Name MLT R694 RUBY LASER SYSTEM
Applicant
Medical Laser Technologies , Ltd.
Unit 4,Belleknowes Industrial
Estate
Inverkeithing,Fife,  GB
Applicant Contact DAVID HAMILTON
Correspondent
Medical Laser Technologies , Ltd.
Unit 4,Belleknowes Industrial
Estate
Inverkeithing,Fife,  GB
Correspondent Contact DAVID HAMILTON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/20/1998
Decision Date 04/03/1998
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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