Modulight ML6710i Laser and ML-SLA

Primary DI: 06429810677020
Brand: Modulight ML6710i Laser and ML-SLA
Company: Modulight Oyj
Model: ML6710i
Device description: 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.
Published: 2023-08-01
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true

Contact Domains#

Code, Name table
Code	Name
MVF	System, Laser, Photodynamic Therapy

Code, Device, Specialty table
Code	Device	Specialty	Class
MVF	System, Laser, Photodynamic Therapy	Unknown	3

Submission, Supplement table
Submission	Supplement
P050026	002

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
P050026	002	QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS	Bausch + Lomb Ireland Limited	2006-04-04	MVF

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
06429810677020	Primary	GS1	0

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifier	GTIN-14 normalized	EAN-13
06429810677020	06429810677020	6429810677020

Term, Definition table
Term	Definition
Ophthalmic diode laser system	An electrically-powered device assembly in which input energy is used to excite a diode to emit a low-power and/or high-power therapeutic laser beam intended for ophthalmic surgery (e.g., ocular incisions, ocular photocoagulation, iridectomy, vitrectomy). Some types may also include an air pump to disperse subretinal fluid in certain procedures (e.g. retinal detachment repair). The laser utilizes a diode/semiconductor chip (as the active medium); it does not include femtosecond pulsing, or fundus imaging technology.

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

Method table
Method

Phone, Email table
Phone	Email
(833) 829-3749	support@modulight.com

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00376128000193	Photofrin® 630 PDT Laser	Pinnacle Biologics, Inc.	MVF	2022-03-11
00376128000179	Photofrin® 630 PDT Laser	Pinnacle Biologics, Inc.	MVF	2018-02-13
00376128000155	Photofrin® 630 PDT Laser	Pinnacle Biologics, Inc.	MVF	2016-09-19
M706417011	BLU-U® Blue Light Photodynamic Therapy Illuminator	DUSA PHARMACEUTICALS INC.	MVF	2014-09-15
M706417021	BLU-U® Blue Light Photodynamic Therapy Illuminator	DUSA PHARMACEUTICALS INC.	MVF	2014-09-15
M706417031	BLU-U® Blue Light Photodynamic Therapy Illuminator	DUSA PHARMACEUTICALS INC.	MVF	2014-09-15