510(k) Report

Devices descending from K160312

14 later devices reach Fraxis Duo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172096FraxisIlooda Co,., Ltd.20172—
+1K170325Secret RFIlooda Co,., Ltd.201710—
+2K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+2K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+2K210084SilkroHironic Co., Ltd.20223—
+2K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+2K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+3K233123SilkroHironic Co., Ltd.20241—
+3K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+3K233099GladiatorRohrer Aesthetics, LLC20240—
+3K233143PiXel8-RevealRohrer Aesthetics20240—
+3K233147PiXel8-RFRohrer Aesthetics20230—
+3K211000AcutronIlooda Co,., Ltd.20220—
+4K251334New Doublo 2.0Hironic Co., Ltd.20250—