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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 K782030
Device Name LASER SYSTEM, SHARPLAN 791/HE, CO2
Applicant
Laser Industries , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Laser Industries , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/05/1978
Decision Date 01/22/1979
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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