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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 K193367
Device Name elysion-pro
High Technology Products SLU
Pasaje Masoliver 24
Barcelona,  ES 08005
Applicant Contact Sergi Lozano
Freyr Global Regulatory Solutions and Services
Level 4 Building No. H-08, Phoenix SEZ Phase 2
Gachibowli, Hyderabad,  IN 500081
Correspondent Contact Vardhini Kirthivas
Regulation Number878.4810
Classification Product Code
Date Received12/04/2019
Decision Date 03/12/2020
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