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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 K153389
Device Name Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)
Applicant
IN LIGHT WELLNESS SYSTEMS, INC.
5601 MIDWAY PARK PLACE NE
ALBUQUERQUE,  NM  87109
Applicant Contact JANE MELONE
Correspondent
MEDICAL QUALITY INTERNATIONAL, LLC
7195 LONGVIEW DRIVE
CLEVELAND,  OH  44139
Correspondent Contact FRED MA
Regulation Number890.5500
Classification Product Code
ILY  
Date Received11/23/2015
Decision Date 03/30/2016
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
Recalls CDRH Recalls
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