FDA.reportPublic FDA data

LED Light Therapy Mask

Primary DI
06978368600108
Brand
LED Light Therapy Mask
Company
Shenzhen Rainbow Technology Co.,Ltd
Model
RB-061
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
06978368600108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978368600108069783686001086978368600108

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
550663864
Device count
1
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
16978368600167LED Light Therapy MaskRB-0532026-02-06
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

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00622356663076Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
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00622356706926Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
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