FDA.reportPublic FDA data

QOLIGHT

Primary DI
06978181510271
Brand
QOLIGHT
Company
Wuhan Qolight Technology Co., Ltd.
Model
ZFT-10J
Published
2026-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06978181510271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978181510271069781815102716978181510271

GMDN Terms#

Term, Definition table
TermDefinition
Trisomy 21 (Down syndrome) IVD, primerA defined piece of single-stranded nucleic acid which binds to and initiates replication of a target nucleic acid template in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inborn genetic disorder Down syndrome, also known as trisomy 21.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
714815435
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978181510325QOLIGHTAngelas-30JN2026-02-10
06978181510301QOLIGHTCoelas-D4E2026-02-02
06978181510318QOLIGHTAngelas-D3C2026-02-02
06978181510240QOLIGHTRemyfx-D3E2026-01-16
06978181510257QOLIGHTRemyfx-D3F2026-01-16
06978181510264QOLIGHTZFT-D4C2026-01-16
06978181510288QOLIGHT109802026-01-16
06978181510295QOLIGHT108082026-01-16
06978181510219EVOEVO D30m2025-12-19
06978181510226EVOEVO S9m2025-12-19
06978181510233EVOEVO Q27m2025-12-19
06978181510202QOLIGHTBELIGHT-15FJ2025-11-12
06978181510196QOLIGHTBELIGHT-15FJ2025-11-05
06978181510165MEDRAYMEDRAY QuantumX2025-10-27
06978181510172MEDRAYMEDRAY-D4C2025-10-27
06978181510189QOLIGHTATLIGHT-60FJ2025-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850012528630ILYEO bodyJoylux, Inc.ILY2026-09-29
00850061407221LS Pro SystemsWELLNESS WITHOUT LIMITS LLCILY2026-09-24
06974958310594mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310600mitoredlightShenzhen 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
09361725025374BON CHARGELight Tree Ventures Europe B.V.ILY2026-08-11
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