LUMIX ULTRA/PLUS LULTRA35HP

GUDID 08057949171584

LASER THERAPY LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm)

FISIOLINE SRL

Skin laser scanner

• Primary Device ID: 08057949171584
• NIH Device Record Key: d8eb8039-d676-49b3-8f29-502cdf1823c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMIX ULTRA/PLUS
• Version Model Number: LUMIX ULTRA 1
• Catalog Number: LULTRA35HP
• 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: 650 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 1064 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 910 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
• 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	08057949171584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161198

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

On-Brand Devices [LUMIX ULTRA/PLUS]

• 08057949171782: LASER THERAPY UNIT LUMIX ULTRA/PLUS with 5 WAVELENGTH (650nm+810nm+910nm+980nm+1064nm)
• 08057949171775: LASER THERAPY UNIT LUMIX ULTRA/PLUS with 5 WAVELENGTH (650nm+810nm+910nm+980nm+1064nm)
• 08057949171768: LASER THERAPY UNIT LUMIX ULTRA/PLUS with 5 WAVELENGTH (650nm+810nm+910nm+980nm+1064nm)
• 08057949171751: LASER THERAPY UNIT LUMIX ULTRA/PLUS with 5 WAVELENGTH (650nm+810nm+910nm+980nm+1064nm)
• 08057949171638: LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+980nm)
• 08057949171621: LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+1064nm)
• 08057949171614: LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910mn+1064nm)
• 08057949171607: LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+980nm)
• 08057949171591: LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm)
• 08057949171584: LASER THERAPY LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm)
• 08057949171577: LASER THERAPY LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm)
• 08057949171560: LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+980nm)