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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 K140005
Device Name ALMA DIODE TABLETOP LASER
Applicant
Alma Lasers , Ltd.
26 Rebecca Ct.
Homosassa,  FL  34446
Applicant Contact KATHY MAYNOR
Correspondent
Alma Lasers , Ltd.
26 Rebecca Ct.
Homosassa,  FL  34446
Correspondent Contact KATHY MAYNOR
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/02/2014
Decision Date 07/18/2014
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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