LUMIX 250 LUMIX250R3

GUDID 08057949171850

LASER THERAPY UNIT LUMIX 250 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 5W

FISIOLINE SRL

Skin laser scanner

• Primary Device ID: 08057949171850
• NIH Device Record Key: 20e62a3d-fa06-4e61-a788-c7a83b0eaab7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMIX 250
• Version Model Number: LUMIX 250
• Catalog Number: LUMIX250R3
• Company DUNS: 338384498
• Company Name: FISIOLINE 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +390172470432
• Email: fisioline@fisioline.com
• Phone: +390172470432
• Email: fisioline@fisioline.com
• Phone: +390172470432
• Email: fisioline@fisioline.com
• Phone: +390172470432
• Email: fisioline@fisioline.com
• Phone: +390172470432
• Email: fisioline@fisioline.com
• Phone: +390172470432
• Email: fisioline@fisioline.com
• Phone: +390172470432
• Email: fisioline@fisioline.com
• Phone: +390172470432
• Email: fisioline@fisioline.com
• Phone: +390172470432
• Email: fisioline@fisioline.com
• Phone: +390172470432
• Email: fisioline@fisioline.com
• Phone: +390172470432
• Email: fisioline@fisioline.com
• Phone: +390172470432
• Email: fisioline@fisioline.com
• Phone: +390172470432
• Email: fisioline@fisioline.com
• Phone: +390172470432
• Email: fisioline@fisioline.com
• Phone: +390172470432
• Email: fisioline@fisioline.com
• Phone: +390172470432
• Email: fisioline@fisioline.com

Device Dimensions

• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057949171850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042256

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: 2023-06-22
• Device Publish Date: 2023-06-14

Devices Manufactured by FISIOLINE SRL

• 08057949170280 - LUMIX CW: 2024-04-23 LASER THERAPY UNIT LUMIX CW with 3 WAVELENGTH (650nm+810nm+1064nm)
• 08057949171911 - LUMIXCPS2HP: 2023-11-08 LASER THERAPY UNIT LUMIX 2 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm)
• 08057949170181 - LUMIX CW: 2023-06-22 LASER THERAPY UNIT LUMIX CW with 2 WAVELENGTH (650nm+1064nm)
• 08057949171560 - LUMIX ULTRA/PLUS: 2023-06-22 LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+980nm)
• 08057949171577 - LUMIX ULTRA/PLUS: 2023-06-22 LASER THERAPY LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm)
• 08057949171584 - LUMIX ULTRA/PLUS: 2023-06-22 LASER THERAPY LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm)
• 08057949171591 - LUMIX ULTRA/PLUS: 2023-06-22 LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm)
• 08057949171607 - LUMIX ULTRA/PLUS: 2023-06-22 LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+980nm)