LUMIX Q LUMIXQ01

GUDID 08057949171645

LASER THERAPY UNIT LUMIX Q with 2 WAVELENGTH (650nm+1064nm)

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

• Primary Device ID: 08057949171645
• NIH Device Record Key: 5ca59772-d1eb-483e-ba2b-8aa7c66d2399
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMIX Q
• Version Model Number: LUMIX C.P.S. 3
• Catalog Number: LUMIXQ01
• 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

Device Dimensions

• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 10 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 1064 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057949171645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160947

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: 2020-09-02
• Device Publish Date: 2020-08-25

Devices Manufactured by FISIOLINE SRL

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• 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)