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

Ophthalmic diode laser system
Primary Device ID06429810677020
NIH Device Record Key02a25127-7411-4ed6-870c-08582086446a
Commercial Distribution StatusIn Commercial Distribution
Brand NameModulight ML6710i Laser and ML-SLA
Version Model NumberML6710i
Company DUNS369410258
Company NameModulight Oyj
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com
Phone(833) 829-3749
Emailsupport@modulight.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This way up.
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care, fragile material inside.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from rain.
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS106429810677020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MVFSystem, Laser, Photodynamic Therapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-09
Device Publish Date2023-08-01

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