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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 K192272
Device Name Wolf445nm
Applicant
A.R.C Laser GmbH
Bessemer St.14
Nurnberg,  DE 90411
Applicant Contact Angela Thyzel
Correspondent
A.R.C Laser GmbH
Bessemer St.14
Nurnberg,  DE 90411
Correspondent Contact Angela Thyzel
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/22/2019
Decision Date 03/17/2020
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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