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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 K170850
Device Name Alma Q
Applicant
Alma Lasers , Ltd.
Halamish St. Pob 3021 Industrial Park
Caesarea,  IL 3088900
Applicant Contact Rekha Anand
Correspondent
Alma Lasers , Ltd.
Halamish St. Pob 3021 Industrial Park
Caesarea,  IL 3088900
Correspondent Contact Rekha Anand
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/22/2017
Decision Date 06/15/2017
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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