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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 K905676
Device Name MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH
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 Received12/18/1990
Decision Date 04/22/1991
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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