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
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
G710L240Velara Lounge 24SUNSHINE USA, LLCILY2026-05-15
G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
00810140063014RENPHOJoicom CorporationILY2026-05-08
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.ILY2026-05-03
00850001456791PRO MED BY JOUVALLE Omm Imports Inc.ILY2026-05-02
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCILY2026-04-23
B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347BDRCKED0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347TB202400000TABLED TECHNOLOGIES INCILY2026-04-23
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
00811485037210PMDShenzhen Fittop Health Technology Co., Ltd.ILY2026-01-16
B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDILY2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorBTL INDUSTRIES LIMITEDILY2025-11-19
G180DIOWAVESTEALTHLIT0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVESTEALTHMAX0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVE50WLS0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-10-31
08906172600074LightdoctorLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10
08906172600081Theraray LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10
00810071230509RegenalaseIPG Medical CorporationILY2025-06-09
00810071230516RegenalaseIPG Medical CorporationILY2025-06-09
00810071230530RegenalaseIPG Medical CorporationILY2025-06-09
16978368600013 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600020 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600037 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05