510(k) Report

Devices descending from K221775

7 later devices reach LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+1K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+1K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+1K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+2K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+2K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+2K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—