LUMIXCPS2HP LUMIXCPS2HP

GUDID 08057949171911

LASER THERAPY UNIT LUMIX 2 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm)

FISIOLINE SRL

Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner

• Primary Device ID: 08057949171911
• NIH Device Record Key: 840d3619-ab87-4407-91d4-15c7962c9976
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMIXCPS2HP
• Version Model Number: LUMIX CPS
• Catalog Number: LUMIXCPS2HP
• 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

Device Dimensions

• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 10 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057949171911 [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: 2023-11-08
• Device Publish Date: 2023-10-31

Devices Manufactured by FISIOLINE SRL

• 08057949170280 - LUMIX CW: 2024-04-23 LASER THERAPY UNIT LUMIX CW with 3 WAVELENGTH (650nm+810nm+1064nm)
• 08057949171911 - LUMIXCPS2HP: 2023-11-08LASER THERAPY UNIT LUMIX 2 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm)
• 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)