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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 K942204
Device Name ARGON CURING LASER
Applicant
Bio-Laser Technology, Inc.
5140 W. Amelia Earhart Dr.
Suite D
Salt Lake City,  UT  84116
Applicant Contact ROBERT S HEAD
Correspondent
Bio-Laser Technology, Inc.
5140 W. Amelia Earhart Dr.
Suite D
Salt Lake City,  UT  84116
Correspondent Contact ROBERT S HEAD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/05/1994
Decision Date 08/26/1994
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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