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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 K011409
Device Name SLT LASERPRO CTH HOLMIUM LASER SYSTEM
Applicant
Surgical Laser Technologies, Inc.
147 Keystone Dr.
Montgomeryville,  PA  18936
Applicant Contact DAVIS WOODWARD
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/08/2001
Decision Date 06/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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