LUMIX ULTRA/PLUS LPLUS1002HP

GUDID 08057949171607

LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+980nm)

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 Skin laser scanner Skin laser scanner Skin laser scanner

• Primary Device ID: 08057949171607
• NIH Device Record Key: 3facd1fb-e17b-432e-8e73-afeb6ce39221
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMIX ULTRA/PLUS
• Version Model Number: LUMIX ULTRA 3
• Catalog Number: LPLUS1002HP
• 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: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer
• Lumen/Inner Diameter: 20 Millimeter
• Lumen/Inner Diameter: 980 Nanometer
• Lumen/Inner Diameter: 910 Nanometer
• Lumen/Inner Diameter: 650 Nanometer

Operating and Storage Conditions

• Handling Environment Humidity: Between 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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	08057949171607 [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)