FDA.reportPublic FDA data

mitoredlight

Primary DI
06974958310600
Brand
mitoredlight
Company
Shenzhen Idea Light Limited
Model
MitoADAPT MID 4.0
Device description
Red Light Device
Published
2026-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974958310600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974958310600069749583106006974958310600

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic red-light phototherapy system, home-useAn assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.

Regulatory Flags#

DUNS number
403696005
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974958310594mitoredlightMitoADAPT MIN 4.02026-09-21
06974958310617mitoredlightMitoADAPT MAX 4.02026-09-21
06974958310624mitoredlightMitoQUAD Belt2026-09-21
06974958310587ideatherapyILC-144AxB112026-07-09
06974958310457LIFEPRO FITNESSLP-RJVGRW-BLK2026-04-17
06974958310549ideatherapyTLM2002026-04-17
06974958310556LIFEPRO FITNESSLP-RVTGLW-WHT2026-04-17
06974958310563LIFEPRO FITNESSLP-RVTGLWP-WHT2026-04-17
06974958310044ideainfraredRTL12C2024-08-16
06974958310082ideainfraredRL60S2024-08-16
06974958310136IdeainfraredTLB1052023-07-27
06974958310143IdeainfraredTLB1202023-07-27
06974958310150 IdeainfraredTLB3002023-07-27
06974958310167NARL05C2023-07-27
16974958310133NATLB105V2023-07-27
16974958310140NATLB120V2023-07-27
16974958310157NATLB300V2023-07-27
16974958310164NARL05C2023-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850061407221LS Pro SystemsWELLNESS WITHOUT LIMITS LLCILY2026-09-24
06974958310594mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310617mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310624mitoredlightShenzhen Idea Light LimitedILY2026-09-21
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
00850087184007HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00860015688989HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00860015688996HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00841436126366LED Instrument CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ILY2026-07-27
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
00850087184038HomedicsFKA DISTRIBUTING CO., LLCILY2026-07-13
08800291820323HEALITE IICynosure Lutronic Technology CorporationILY2026-06-23
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27