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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 K043317
Device Name OMNILUX PLUS
Original Applicant
PHOTO THERAPEUTICS LIMITED
station house
stamford new road
altrincham, cheshire,  UK wa14 1ep
Original Contact steven g hutson
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/02/2004
Decision Date 03/15/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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