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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
Applicant
High Technology Products SLU
Pasaje Masoliver 24
barcelona,  ES 08005
Applicant Contact sergi lozano
Correspondent
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
GEX  
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
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