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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K173436
Device Name Luma Light System
Applicant
Luma Therapeutics
10 Rollins Rd.
Suite 120
Millbrae,  CA  94030
Applicant Contact Tiffini Wittwer
Correspondent
Luma Therapeutics
10 Rollins Rd.
Suite 120
Millbrae,  CA  94030
Correspondent Contact Tiffini Wittwer
Regulation Number878.4630
Classification Product Code
FTC  
Date Received11/03/2017
Decision Date 01/30/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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