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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 K191321
Device Name Primelase Excellence
Applicant
High Technology Products S.L.U
Pasaje Masoliver 24
Barcelona,  ES 08005
Applicant Contact Sergi Lozano
Correspondent
Freyr Global Regulatory Solutions and Services
Level 4 Bldg. # H-08
Phoenix Sez Phase 2
Gachibowli, Hyderabad,  IN 500081
Correspondent Contact Vardhini Kirthivas
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/15/2019
Decision Date 08/02/2019
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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