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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 K222205
Device Name Cold Sore Device (Model: QPZ-01)
Applicant
Light Tree Ventures Europe B.V.
Laan Van Ypenburg 108, 2497 Gc, The Hague, The Netherlands
Hague,  NL
Applicant Contact Alain Dijkstra
Correspondent
Light Tree Ventures Europe B.V.
Laan Van Ypenburg 108, 2497 Gc, The Hague, The Netherlands
Hague,  NL
Correspondent Contact Alain Dijkstra
Regulation Number878.4860
Classification Product Code
OKJ  
Date Received07/25/2022
Decision Date 10/07/2022
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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