510(k) Report

Devices descending from K231555

1 later device reach LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—