Modulight ML6710i Laser and ML-SLA

GUDID 06429810677020

The intended use for the ML6710i laser is photoactivation of VISUDYNE® (verteporfin for injection), which is a light-activated drug used in photodynamic therapy (PDT) for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis. Please consult the VISUDYNE® (Bausch & Lomb Incorporated) prescribing information for additional information on intended use, recommended drug and light dose, administration instructions, contraindications, warnings and precautions, and side effects of VISUDYNE® treatment.

Modulight Oyj

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• Primary Device ID: 06429810677020
• NIH Device Record Key: 02a25127-7411-4ed6-870c-08582086446a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modulight ML6710i Laser and ML-SLA
• Version Model Number: ML6710i
• Company DUNS: 369410258
• Company Name: Modulight Oyj
• 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: true
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com
• Phone: (833) 829-3749
• Email: support@modulight.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This way up.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care, fragile material inside.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from rain.
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	06429810677020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050026

FDA Product Code

• MVF: System, Laser, Photodynamic Therapy

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: 2023-08-09
• Device Publish Date: 2023-08-01