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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 K152087
Device Name HeatLux Pro II
Applicant
Home Skinovations , Ltd.
Tabor Bldg., Shaar Yokneam
Yokneam,  IL 2069200
Applicant Contact Ahava Stein
Correspondent
A. Stein - Regulatory Affairs Consulting , Ltd.
20 Hata'As St. , Suite 102
K Far Saba,  IL 4442520
Correspondent Contact Ahava Stein
Regulation Number890.5500
Classification Product Code
ILY  
Subsequent Product Code
GEI  
Date Received07/27/2015
Decision Date 07/29/2016
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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