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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fat Reducing Low Level Laser
510(k) Number K160880
Device Name Photonica Professional
Applicant
Ward Photonics, LLC
1980 N Atlantic Ave.
Cocoa Beach,  FL  32931
Applicant Contact Terry Ward
Correspondent
Alliance Lifescience Partnerships, LLC
1260 Bell View Cir.
Sany,  UT  84094
Correspondent Contact Jeff Brown
Regulation Number878.5400
Classification Product Code
OLI  
Date Received03/30/2016
Decision Date 09/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02867150
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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