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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 K944317
Device Name GENESIS 2000
Applicant
Ion Laser Technology
3828 S. Main St.
Salt Lake City,  UT  84115
Applicant Contact J. RAYMOND KEMPLE
Correspondent
Ion Laser Technology
3828 S. Main St.
Salt Lake City,  UT  84115
Correspondent Contact J. RAYMOND KEMPLE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/29/1994
Decision Date 10/11/1994
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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