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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 K972765
Device Name NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASER
Applicant
American Laser Medical
1832 S. 3850 W.
Salt Lake City,  UT  84104
Applicant Contact DANIEL HOEFER
Correspondent
American Laser Medical
1832 S. 3850 W.
Salt Lake City,  UT  84104
Correspondent Contact DANIEL HOEFER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/24/1997
Decision Date 10/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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