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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 K140470
Device Name OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER
Applicant
Oberon GmbH Fiber Technologies
7404 W. Detroit St., Suite 140
Chandler,  AZ  85226
Applicant Contact ARMIN KAUS
Correspondent
Oberon GmbH Fiber Technologies
7404 W. Detroit St., Suite 140
Chandler,  AZ  85226
Correspondent Contact ARMIN KAUS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/25/2014
Decision Date 10/15/2014
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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