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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Treatment For Cold Sores Herpes Simplex Virus-1
510(k) Number K251973
Device Name Luminance Red Cold Sore Device (TN1927G)
Applicant
Luminance Medical Ventures, Inc.
2310 Henderson Ave.
#1297
Dallas,  TX  75201
Applicant Contact Troy Stites
Correspondent
Medlaunch, LLC
17437 Carey Rd.
#102
Westfield,  IN  46074
Correspondent Contact Nathan Glass
Regulation Number878.4860
Classification Product Code
OKJ  
Date Received06/26/2025
Decision Date 09/23/2025
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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