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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical Coagulation For Aesthetic
510(k) Number K130283
Device Name EVRF SYSTEM
Applicant
F Care Systems NV
1468 Harwell Ave.
Crofton,  MD  21114
Applicant Contact E. J SMITH
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number878.4400
Classification Product Code
ONQ  
Date Received02/05/2013
Decision Date 03/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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