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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
Applicant
BIOPHOTAS, INC.
28241 CROWN VALLEY PARKWAY, SUITE 510(K)
LAGUNA NIGUEL,  CA  92677
Applicant Contact SHEPARD G BENTLEY, RAC
Correspondent
BIOPHOTAS, INC.
28241 CROWN VALLEY PARKWAY, SUITE 510(K)
LAGUNA NIGUEL,  CA  92677
Correspondent 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 (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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