FDA.reportPublic FDA data

LED Light Therapy Mask

Primary DI
16978368600303
Brand
LED Light Therapy Mask
Company
Shenzhen Rainbow Technology Co.,Ltd
Model
RB-030
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.
Published
2025-06-05
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243423000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243423000LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)Shenzhen Rainbow Technology Co., Ltd.2025-01-28OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16978368600303PrimaryGS10
06978368600306Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697836860030316978368600303
06978368600306069783686003066978368600306

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
10
Lot or batch
true
Serial number
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850001456814Velora REDOmm Imports Inc.OHS2026-07-26
00810140062833RENPHOJoicom CorporationILY2026-07-24
00810140063113RENPHOJoicom CorporationILY2026-07-24
00810140063120RENPHOJoicom CorporationILY2026-07-24
00850083596002LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850083596026LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850026680218Aura WellnessAura Wellness, LLCILY2026-07-21
08800020111852HILTHERAJeisys Medical Inc.ILY2026-07-21
06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600029BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600029BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600036BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600036BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
00850087184038HomedicsFKA DISTRIBUTING CO., LLCILY2026-07-13
00860015912503BOB AND BRADAmazing Impulse, LLCOHS2026-07-06
00860015912503BOB AND BRADAmazing Impulse, LLCOLP2026-07-06
00810140063090RenphoJoicom CorporationOHS2026-06-23
00810140063090RenphoJoicom CorporationOLP2026-06-23
08800291820323HEALITE IICynosure Lutronic Technology CorporationILY2026-06-23
00622356646390Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356646390Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02