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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 K950826
Device Name AM RUBY
Applicant
American Lasers, Inc.
300 E. Main St.
Alhambra,  CA  91801
Applicant Contact DAVID K QUON
Correspondent
American Lasers, Inc.
300 E. Main St.
Alhambra,  CA  91801
Correspondent Contact DAVID K QUON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/23/1995
Decision Date 11/29/1995
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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