FDA.reportPublic FDA data

LED Light Therapy Mask

Primary DI
16978368600167
Brand
LED Light Therapy Mask
Company
Shenzhen Rainbow Technology Co.,Ltd
Model
RB-053
Device description
*Red+Infrared light: Treatment of full-face wrinkles. *Red light: Treatment of full-face wrinkles. *Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm;relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. *Blue light: Treatment of mild to moderate inflammatory acne. *Red+Blue light: Treatment of mild to moderate inflammatory acne.
Published
2026-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating
OHSLight Based Over The Counter Wrinkle Reduction
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16978368600167PrimaryGS10
06978368600160Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697836860016716978368600167
06978368600160069783686001606978368600160

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.

Regulatory Flags#

DUNS number
550663864
Device count
6
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978368600238DreameAB01A2026-04-07
06978368600221DreameRB-0532026-04-07
06978368600245DreameAB01P2026-04-07
06978368600108LED Light Therapy MaskRB-0612026-02-06
16978368600105LED Light Therapy MaskRB-0612026-02-06
06978368600160LED Light Therapy MaskRB-0532026-02-06
06978368600085LED Light Therapy Mask-GYHRB-0082025-06-18
06978368600016 LED Light Therapy MaskRB-008G2025-06-18
06978368600023 LED Light Therapy MaskRB-008GB2025-06-18
06978368600030 LED Light Therapy MaskRB-008J2025-06-18
06978368600047LED Light Therapy MaskRB-008JB2025-06-18
06978368600054LED Light Therapy Mask - HIME SAMARB-0082025-06-18
06978368600306 LED Light Therapy MaskRB-0302025-06-18
06978368600818 LED Light Therapy MaskRB-0812025-06-18
16978368600013 LED Light Therapy MaskRB-008G2025-06-05
16978368600020 LED Light Therapy MaskRB-008GB2025-06-05
16978368600037 LED Light Therapy MaskRB-008J2025-06-05
16978368600044LED Light Therapy MaskRB-008JB2025-06-05
16978368600051LED Light Therapy Mask - HIME SAMARB-0082025-06-05
16978368600303 LED Light Therapy MaskRB-0302025-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974639600495IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHS2026-08-27
06974639600495IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHS2026-08-27
06979994630002CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630019CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630026CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630033CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630040CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
08800190200004OLIZLTBIO Co., Ltd.ILY2026-08-26
06977782490029QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
06977782490036QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
B5171301410Energy Flo TDP Heat LampAcu MarketILY2026-08-21
00860016300309LMNTXPLR LTDOLP2026-08-17
00860016300309LMNTXPLR LTDOHS2026-08-17
06980299090002ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090002ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
06980299090019ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
06980299090019ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090026ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
06980299090026ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
09361725025404BON CHARGELight Tree Ventures Europe B.V.OHS2026-08-11
09361725025411BON CHARGELight Tree Ventures Europe B.V.OHS2026-08-11
05060534511521ELEMIS Red Light MaskI-SMART DEVELOPMENTS LIMITEDOHS2026-08-07
00622356746410Shark™ CryoGlow Plus™SharkNinja Operating LLCOHS2026-08-01
00622356746410Shark™ CryoGlow Plus™SharkNinja Operating LLCOLP2026-08-01
00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOLP2026-08-01
00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOHS2026-08-01
00850087184007HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00860015688989HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01