510(k) Report

Devices descending from K230293

16 later devices reach TheraFace Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+1K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+1K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+1K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+1K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+2K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+2K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+2K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+2K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+2K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+2K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+2K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+2K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+3K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+3K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+3K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—