FDA.reportPublic FDA data

510(k) K261496

Device
LED Light Therapy Masks (PE748, PE749, PE756)
Applicant
Duplex International Trading Limited
510(k) number
K261496
Product code
OHS
Decision
Substantially Equivalent (SESE)
Decision date
2026-08-04
Date received
2026-05-06
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
JunYi Xing
Address
B1, 10/F, Block 2, Golden Dragon Ind Center, 162-170 Tai Lin Hongkong CN

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
K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.2026-08-07
K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.2026-08-04
K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC2026-07-31
K2605985 Wavelength LED Facemask (TN2508)iSMART Developments, Ltd.2026-07-24
K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)Dongguan Miqiang Technology Co., Ltd.2026-07-15
K261473ChromixTermosalud S.L.2026-07-01
K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.2026-06-29
K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.2026-06-18
K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.2026-06-16
K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.2026-06-03
K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.2026-05-12
K260150LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)NOOANCE2026-04-22
K260202LED Light Therapy Masks (LumiLips FAC07NA)Guangdong Newdermo Biotech Co., Ltd.2026-03-23
K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.2026-03-16
K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.2026-03-16