510(k) Report

Devices descending from DEN150005

9 later devices reach Newa Skin Therapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+1K170499sensiLiftEl Global Trade, Ltd.20171—
+1K162784Silk'n HSTHome Skinovations, Ltd.20171—
+2K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+2K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+2K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+3K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+4K233766Geneo X ElitePollogen, Ltd.20240—
+4K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—