PASCAL LIO, 532nm

Basic Information

• Brand Name: PASCAL LIO, 532nm
• Primary DI: 00813125016807
• Version / Model: LIO for Synthesis 532
• Catalog Number: SA-06171
• Company Name: IRIDEX CORPORATION
• Labeler DUNS: 612920785
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-22
• Public Version: 1
• Public Version Date: 2021-11-01
• Public Version Status: New
• Public Device Record Key: ec803458-1dbf-474b-ab74-d038199de775

Device Description

KIT, PASCAL LIO, 532nm, PASCAL Synthesis IRIDEX

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQF	Laser, Ophthalmic	Ophthalmic	886.4390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32729	Indirect binocular laser ophthalmoscope	An electrically-powered, head-worn, ophthalmic device used for the stereoscopic examination and laser treatment of the eye, particularly the retina. It typically consists of a headband, a built-in light with aperture control for adjustment of the illumination field, convergence controls to synchronize the illumination and examination beams, a delivery mirror, filters to protect the surgeon against incidental laser-beam reflection, and a power-supply cable for the lighting, and a fibreoptic cable to convey the laser beam. This device is connected to an appropriate laser for delivery of laser energy.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813125016807	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123056	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 0 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius