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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 K911852
Device Name COMPULSE CO2 SURGICAL LASER SYS.
Applicant
Laser Engineering, Inc.
113 Cedar St.
Milford,  MA  01757
Applicant Contact ROBERT I.RUDKO
Correspondent
Laser Engineering, Inc.
113 Cedar St.
Milford,  MA  01757
Correspondent Contact ROBERT I.RUDKO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/26/1991
Decision Date 06/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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