FDA.reportPublic FDA data

510(k) K262752

Device
Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)
Applicant
Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.
510(k) number
K262752
Product code
OHS
Decision
Substantially Equivalent (SESE)
Decision date
2026-10-23
Date received
2026-08-03
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
Tian fei He
Address
3rd Floor,Bldg. A #281 Huating Rd., Shuiwei Community, Dalan Shenzhen CN 518109 518109

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
K262932AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3)Shenzhen Accompany Technology Co., Ltd.2026-10-19
K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)Kam Yuen Plastic Products , Ltd.2026-08-31
K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.2026-08-10
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
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