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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 K150175
Device Name HeatLux Pro I
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  
Date Received01/26/2015
Decision Date 03/31/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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