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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 K100213
Device Name LUMANOSITY CELEBRITY, MODEL 204
Applicant
LUMANOSITY, INC
11271 VENTURA BLVD
SUITE 212
STUDIO CITY,  CA  91604
Applicant Contact JEFF PROVISSIERO
Correspondent
LUMANOSITY, INC
11271 VENTURA BLVD
SUITE 212
STUDIO CITY,  CA  91604
Correspondent Contact JEFF PROVISSIERO
Regulation Number890.5500
Classification Product Code
ILY  
Date Received01/25/2010
Decision Date 10/04/2010
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
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