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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 K120582
Device Name HEATLUX
Applicant
HOME SKINOVATIONS LTD.
TAVOR BULD. POB 533
YOKNEAM ILLIT,  IL 20692
Applicant Contact AMIR WALDMAN, PH.D
Correspondent
HOME SKINOVATIONS LTD.
TAVOR BULD. POB 533
YOKNEAM ILLIT,  IL 20692
Correspondent Contact AMIR WALDMAN, PH.D
Regulation Number890.5500
Classification Product Code
ILY  
Date Received02/27/2012
Decision Date 07/06/2012
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
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