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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 K192951
Device Name Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
Applicant
Ellipse A/S
Agern Alle 11
Hoersholm,  DK dk-2970
Applicant Contact Ole Kofod
Correspondent
Ellipse A/S
Agern Alle 11
Hoersholm,  DK dk-2970
Correspondent Contact Ole Kofod
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/21/2019
Decision Date 03/26/2020
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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