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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 K910602
FOIA Releasable 510(k) K910602
Device Name HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY
Applicant
Hgm Medical Laser Systems, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Applicant Contact DENNIS REIGLE
Correspondent
Hgm Medical Laser Systems, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Correspondent Contact DENNIS REIGLE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/13/1991
Decision Date 06/24/1991
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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