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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered light based non-laser surgical instrument with thermal effect
510(k) Number K140668
Device Name PLATINUMGMT IPL SYSTEM CLOUD
Applicant
GLOBAL MEDICAL TECHNOLOGY S.L.
C/ Isla de Alegranza 2
Nave 51
san sebastian de los reyes,  ES 28703
Applicant Contact derliz david diaz sanchez
Correspondent
MedicSense, USA
291 Hillside Avenue
somerset,  MA  02726
Correspondent Contact george hattub
Regulation Number878.4810
Classification Product Code
ONF  
Date Received03/18/2014
Decision Date 12/19/2014
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
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