510(k) Report

Devices descending from K101716

5 later devices reach HVR Pain Relief Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+1K162763Vevazz LED Heat LampVevazz, LLC20170—
+1K120582HeatluxHome Skinovations, Ltd.20123—
+2K150175HeatLux Pro IHome Skinovations, Ltd.20151—
+3K152087HeatLux Pro IIHome Skinovations, Ltd.20160—