K-Laser

Primary DI
B317SPCLTHP0
Brand
K-Laser
Company
ELTECH KLASER SRL
Model
Speciale Live Therapy Plus
Device description
Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation
Published
2021-07-28
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B317SPCLTHP0PrimaryHIBCC0

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), 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 table
Method

Regulatory Flags#

DUNS number
654931570
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
B317KLGCHUF0GIROGIRO COREPF402U2026-05-27
B317KLGEHUF0GIROGIRO ELITEPF401U2026-05-27
B317KLGUHUF0GIROGIRO ULTRAPF400U2026-05-27
B317KPLUS300K-LaserK-Laser Cube Plus 302020-06-01
B317SPCLTHM0K-LaserSpeciale Live Therapy2022-06-23
B317KPERF300K-LaserK-Laser Cube Performance 302020-04-30
B317KCUBE0K-LaserK-Laser Cube2016-09-06
B317KCUBE20K-LaserK-Laser Cube22016-09-06
B317KCUBE30K-LaserK-Laser Cube32016-09-06
B317KCUBE40K-LaserK-Laser Cube42016-09-06
B317KCUBE4P0K-LaserK-Laser Cube4 Performance2018-09-26

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