FDA.reportPublic FDA data

CureLight Medical Diode Laser Systems

Primary DI
06976563460046
Brand
CureLight Medical Diode Laser Systems
Company
Wuhan PHOMED Technology Co., Ltd.
Model
CureLight F2-B30
Published
2025-10-09
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253965000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253965000CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)Wuhan PHOMED Technology Company , Ltd.2026-03-19ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976563460046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976563460046069765634600466976563460046

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableAn electrically-powered device intended for use in the home or clinical setting to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
725228743
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976563460015CureLight Medical Diode Laser SystemsCureLight F2-A152025-10-09
06976563460022CureLight Medical Diode Laser SystemsCureLight F2-B152025-10-09
06976563460039CureLight Medical Diode Laser SystemsCureLight F2-A302025-10-09
06976563460053CureLight Medical Diode Laser SystemsCureLight F3-AB302025-10-09
06976563460060CureLight Medical Diode Laser SystemsCureLight F3-AB602025-10-09
06976563460077CureLight Medical Diode Laser SystemsCureLight F4-ABCR452025-10-09
06976563460084CureLight Medical Diode Laser SystemsCureLight F4-ABDR452025-10-09
06976563460091CureLight Medical Diode Laser SystemsCureLight F4-ACDR452025-10-09
06976563460107CureLight Medical Diode Laser SystemsCureLight S3-BF452025-06-12
06976563460206VelasII Therapy Laser SystemAscent2025-06-06

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Primary DI, Brand, Company table
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00850026680218Aura WellnessAura Wellness, LLCILY2026-07-21
08800020111852HILTHERAJeisys Medical Inc.ILY2026-07-21
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B347TB202400000TABLED TECHNOLOGIES INCILY2026-04-23
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
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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