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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K080318
Device Name ALMA LASER NIR MODULE
Applicant
Alma Lasers , Ltd.
Halamish St. Pob 3021
Industrial Park
Caesarea,  IL 38900
Applicant Contact TATIANA EPSTEIN
Correspondent
Alma Lasers , Ltd.
Halamish St. Pob 3021
Industrial Park
Caesarea,  IL 38900
Correspondent Contact TATIANA EPSTEIN
Regulation Number890.5500
Classification Product Code
ILY  
Date Received02/06/2008
Decision Date 03/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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