FDA.report

IR-20

Primary DI
00866085000409
Brand
IR-20
Company
IVIMEA
Model
IR-20
Published
2017-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications

CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00866085000409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00866085000409008660850004098660850004090866085000409

GMDN Terms

TermDefinition
Musculoskeletal/physical therapy laser, professionalAn electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improving blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for internal (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated by a healthcare professional exclusively in a clinical setting.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080811140
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
09361725008346BON CHARGELight Tree Ventures Europe B.V.ILY2026-05-25
09361725008360BON CHARGELight Tree Ventures Europe B.V.ILY2026-05-25
06976812430219TheraLight 360 Full Body WellnessRhein Laser Technologies Co.,Ltd.ILY2026-03-06
06976812430226TheraLight 360 Full Body WellnessRhein Laser Technologies Co.,Ltd.ILY2026-03-06
06976812430233TheraLight 360 Full Body WellnessRhein Laser Technologies Co.,Ltd.ILY2026-03-06
06977863220149Therapy LightE.SHINE LIGHTING CO., LIMITEDILY2026-03-02
06977863220156Therapy LightE.SHINE LIGHTING CO., LIMITEDILY2026-03-02
06977863220163Therapy LightE.SHINE LIGHTING CO., LIMITEDILY2026-03-02
06977863220170Therapy LightE.SHINE LIGHTING CO., LIMITEDILY2026-03-02
06979292890009SummusLasxbot (Shenzhen) Robot Co., LtdILY2026-02-27
08500723550001SunPowerLEDKERBER USA INC.ILY2026-02-26
08500723550018SunPowerLEDKERBER USA INC.ILY2026-02-26
08500723550025SunPowerLEDKERBER USA INC.ILY2026-02-26
08500723550049SunPowerLEDKERBER USA INC.ILY2026-02-26
08500723550056SunPowerLEDKERBER USA INC.ILY2026-02-26
08500723550063SunPowerLEDKERBER USA INC.ILY2026-02-26
00840397513284Sharper ImageMerchsource, LLCILY2026-02-17
06977782490005Quasar MDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-02-11
06978181510325QOLIGHTWuhan Qolight Technology Co., Ltd.ILY2026-02-10
06956822893013SolawaveShenzhen Goodwind technology development Co.,LtdILY2026-02-04
06956822893020SolawaveShenzhen Goodwind technology development Co.,LtdILY2026-02-04
06956822893037SolawaveShenzhen Goodwind technology development Co.,LtdILY2026-02-04
06978181510301QOLIGHTWuhan Qolight Technology Co., Ltd.ILY2026-02-02
06978181510318QOLIGHTWuhan Qolight Technology Co., Ltd.ILY2026-02-02
06979812520034MarrisJjwXiamen Langxing Medical Technology Co., Ltd.ILY2026-01-26
06979322350015N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22
06979322350022N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22
06979322350039N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22
06979322350046N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22
06979322350053N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22