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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 K974142
Device Name HM-RUBY
Applicant
American Lasers, Inc.
808 N. Hill St.
Attn: David K. Quon, Md/Pres.
Los Angeles,  CA  90011
Applicant Contact DAVID K QUON
Correspondent
American Lasers, Inc.
808 N. Hill St.
Attn: David K. Quon, Md/Pres.
Los Angeles,  CA  90011
Correspondent Contact DAVID K QUON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/03/1997
Decision Date 01/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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