510(k) Report

Devices descending from DEN090012

3 later devices reach Virulite Cold Sore Machine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222205Cold Sore Device (Model: QPZ-01)Light Tree Ventures Europe B.V.20222—
+2K251973Luminance Red Cold Sore Device (TN1927G)Luminance Medical Ventures, Inc.20250—
+2K241155Cold Sore Device (QPZ-03)Shenzhen Nuon Medical Equipment Co., Ltd.20240—