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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 K110941
Device Name REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200
Applicant
Allmed Systems, Inc.
9232 Klemetson Dr.
Pleasanton,  CA  94588
Applicant Contact PETER ALLEN
Correspondent
Allmed Systems, Inc.
9232 Klemetson Dr.
Pleasanton,  CA  94588
Correspondent Contact PETER ALLEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/04/2011
Decision Date 02/19/2013
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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