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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 K904126
Device Name VISIRASER
Applicant
Acorn Group, Inc.
47 Quail Ct.
Suite 301
Walnut Creek,  CA  94596
Applicant Contact JAMES P STOUT
Correspondent
Acorn Group, Inc.
47 Quail Ct.
Suite 301
Walnut Creek,  CA  94596
Correspondent Contact JAMES P STOUT
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/06/1990
Decision Date 10/30/1990
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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