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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 K212073
Device Name Alma Diode Tabletop Laser
Applicant
Alma Lasers , Ltd.
18 Haharash St., N. Industrial Park
Caesarea,  IL 3079895
Applicant Contact Avi Hirshnzon
Correspondent
Hoy & Associates Regulatory Consulting
1830 Bonnie Way
Sacramento,  CA  95825
Correspondent Contact Connie Hoy
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/02/2021
Decision Date 07/14/2022
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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