K-Laser

GUDID B317KCUBE20

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

ELTECH KLASER SRL

Musculoskeletal/physical therapy laser, professional

• Primary Device ID: B317KCUBE20
• NIH Device Record Key: 64b58b11-b341-4070-850a-10753094ea6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-Laser
• Version Model Number: K-Laser Cube2
• Company DUNS: 654931570
• Company Name: ELTECH KLASER SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B317KCUBE20 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120604

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-06

On-Brand Devices [K-Laser]

• B317KCUBE4P0: Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the
• B317KCUBE40: Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the
• B317KCUBE30: Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the
• B317KCUBE20: Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the
• B317KCUBE0: Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the
• B317KPERF300: Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the
• B317SPCLTHP0: Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the
• B317SPCLTHM0: Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the
• B317KPLUS300: Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the