FDA.reportPublic FDA data

510(k) K260715

Device
CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)
Applicant
The Beauty Tech Group, Ltd.
510(k) number
K260715
Product code
OHS
Decision
Substantially Equivalent (SESE)
Decision date
2026-06-03
Date received
2026-03-05
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
Harriet Cavanagh
Address
Glasshouse, Suite 3f1, Congleton Rd. Macclesfield GB SK10 4ZE SK10 4ZE

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
K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited2026-08-04
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
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