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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 K122237
Device Name BIOPHOTAS LIFELIGHT
Original Applicant
BIOPHOTAS, INC.
28241 crown valley parkway, suite 510(k)
laguna niguel,  CA  92677
Original Contact shepard g bentley, rac
Regulation Number890.5500
Classification Product Code
ILY  
Subsequent Product Code
GEX  
Date Received07/26/2012
Decision Date 01/03/2013
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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