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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 K152280
Device Name BioPhotas Celluma3
Applicant
Biophotas, Inc.
250 El Camino Real, #110
Tustin,  CA  92780
Applicant Contact PATRICK JOHNSON
Correspondent
Qpm Consulting, LLC
3817 Seville Rd.
Denton,  TX  76205
Correspondent Contact ROBERT SEIPLE
Regulation Number890.5500
Classification Product Code
ILY  
Subsequent Product Codes
OHS   OLP  
Date Received08/12/2015
Decision Date 03/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Clinical Trials NCT02543970
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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