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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 K060792
Device Name ILLUMIMED
Applicant
PHOTOACTIF, LLC
1959 SOUTH POWER RD
SUITE 103-313
MESA,  AZ  85206
Applicant Contact JEREMY SHELLMAN
Correspondent
PHOTOACTIF, LLC
1959 SOUTH POWER RD
SUITE 103-313
MESA,  AZ  85206
Correspondent Contact JEREMY SHELLMAN
Regulation Number890.5500
Classification Product Code
ILY  
Subsequent Product Code
GEX  
Date Received03/23/2006
Decision Date 12/01/2006
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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