510(k) K260150

Device
LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)
Applicant
NOOANCE
510(k) number
K260150
Product code
OHS
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-22
Date received
2026-01-20
Regulation
878.4810
Classification name
Light Based Over The Counter Wrinkle Reduction
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Carole Amar
Address
22 Rue Beaujon Paris FR 75008 75008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OHS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.2026-05-12
K260202LED Light Therapy Masks (LumiLips FAC07NA)Guangdong Newdermo Biotech Co., Ltd.2026-03-23
K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.2026-03-16
K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.2026-03-16
K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.2026-03-03
K253683FAQ™ (LED Panel); FAQ™ (Dual LED Panel)Foreo, Inc.2026-02-20
K254007LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)SZ KKS Silicone&Electronic Co., Ltd.2026-02-12
K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)Shenzhen Jianchao Intelligent Technology Co., Ltd.2026-01-30
K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.2026-01-28
K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)Shenzhen Rainbow Technology Co., Ltd.2026-01-23
K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)Shenzhen Saidi Light Therapy Technology Co., Ltd.2025-12-24
K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC2025-12-24
K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)Dongguan Yijiaming Technology Co., Ltd.2025-12-23
K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.2025-12-19
K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.2025-12-19