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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 K001031
Device Name URANUS, COMFORTOUCH LASER SYSTEM
Applicant
Laser Max Medical Technologies Corp.
1601 N. Clancy St.
Visalia,  CA  93291
Applicant Contact PAUL Y FANG
Correspondent
Laser Max Medical Technologies Corp.
1601 N. Clancy St.
Visalia,  CA  93291
Correspondent Contact PAUL Y FANG
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/30/2000
Decision Date 06/29/2000
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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