AccessGUDID - DEVICE: Modulight ML6710i Laser and ML-SLA (06429810677020)

GUDID

Device Identifier (DI) Information

Brand Name: Modulight ML6710i Laser and ML-SLA
Version or Model: ML6710i
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Modulight Oyj

Primary DI Number: 06429810677020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 369410258 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62161	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.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P050026	002

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 02a25127-7411-4ed6-870c-08582086446a
Public Version Date: August 09, 2023
Public Version Number: 1
DI Record Publish Date: August 01, 2023