iLux LF HPS R2

GUDID 08051499971403

The device is 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. It is also indicated for promoting relaxation of the muscle tissue and for temporarily increasing local blood circulation.

MECTRONIC MEDICALE SRL

Musculoskeletal/physical therapy laser, professional

• Primary Device ID: 08051499971403
• NIH Device Record Key: ff2fbdb3-2d38-420d-b92c-6e0262108f87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLux LF HPS R2
• Version Model Number: 1LFHR2
• Company DUNS: 429098838
• Company Name: MECTRONIC MEDICALE SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08051499971403 [Primary]

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-18
• Device Publish Date: 2024-10-10

Devices Manufactured by MECTRONIC MEDICALE SRL

• 08051499971007 - CHELT F EB 60: 2024-12-06 CHELT is a medical device for laser and cryo therapy, designed to provide topical heating for the purpose of elevating tissues t
• 08051499974084 - iLux LF D12: 2024-12-06 The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperatur
• 08051499974107 - iLux LF D25: 2024-12-06 The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperatur
• 08051499970758 - Ixyon XP F50 ED: 2024-10-18 The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperatur
• 08051499970765 - Ixyon XP F92 OA: 2024-10-18 The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperatur
• 08051499971304 - iLux LF Y10: 2024-10-18 The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperatur
• 08051499971328 - iLux LF HPS Y15: 2024-10-18 The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperatur
• 08051499971335 - iLux LF HPS D10: 2024-10-18 The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperatur