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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 K203441
Device Name The Alma Hybrid Laser System
Applicant
Alma Lasers, Ltd.
18 Haharash Street, North Industrial Park
Caesarea Ha Zafon,  IL 3079895
Applicant Contact Avi Hirshnzon
Correspondent
Alma Lasers, Ltd.
18 Haharash Street, North Industrial Park
Caesarea Ha Zafon,  IL 3079895
Correspondent Contact Avi Hirshnzon
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/23/2020
Decision Date 07/02/2021
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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