CuraBeam

Primary DI
06979994630033
Brand
CuraBeam
Company
CuraBeam Medical Technology Co.,Ltd.
Model
CuraH625
Device description
The CuraH625 is a prescription Class 4 laser therapy system intended for professional use in medical institutions. It utilizes photobiomodulation with six wavelengths (650nm, 810nm, 915nm, 940nm, 980nm, 1064nm) to provide temporary relief of minor muscle and joint pain, stiffness, arthritis pain, and muscle spasm, as well as to temporarily increase local blood circulation and relax muscles. The device features a 10.1-inch touchscreen interface, multiple treatment heads (non-contact, contact, and curved), and offers both protocol and custom treatment modes. Maximum output power: 25W (IR wavelengths) and 160mW (650nm). It includes safety features such as emergency stop, remote interlock, and password protection.
Published
2026-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
06979994630033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06979994630033069799946300336979994630033

GMDN Terms#

Term, Definition table
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), improvement of local 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 intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional.

Regulatory Flags#

DUNS number
778288116
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979994630002CuraBeamCuraH6352026-08-26
06979994630019CuraBeamCuraH32026-08-26
06979994630026CuraBeamCuraR22026-08-26
06979994630040CuraBeamCuraH6302026-08-26

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Primary DI, Brand, Company table
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