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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 K091059
Device Name FOXQ 980 LASER
Applicant
A.R.C Laser GmbH
3202 Tower Oaks Blvd. Suite 300
Rockville,  MD  20852
Applicant Contact KIRSTEN PAULSON
Correspondent
A.R.C Laser GmbH
3202 Tower Oaks Blvd. Suite 300
Rockville,  MD  20852
Correspondent Contact KIRSTEN PAULSON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/14/2009
Decision Date 08/13/2009
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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