PASCAL LIO, 532nm SA-06171

GUDID 00813125016807

KIT, PASCAL LIO, 532nm, PASCAL Synthesis IRIDEX

IRIDEX CORPORATION

Indirect binocular laser ophthalmoscope

• Primary Device ID: 00813125016807
• NIH Device Record Key: ec803458-1dbf-474b-ab74-d038199de775
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASCAL LIO, 532nm
• Version Model Number: LIO for Synthesis 532
• Catalog Number: SA-06171
• Company DUNS: 612920785
• Company Name: IRIDEX CORPORATION
• 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: false
• 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: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813125016807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123056

FDA Product Code

• HQF: Laser, Ophthalmic

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: 2021-11-01
• Device Publish Date: 2021-10-22

Devices Manufactured by IRIDEX CORPORATION

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• 00813125010263 - Eye Safety Filter, Two-Position (532 nm): 2024-10-30 For use on the Leica or Wild Dovetails OD3 @ 532 nm
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• 00813125014506 - Eye Safety Filter, Two-Position (577 nm): 2024-10-30 For use on the Zeiss Dovetails OD3 @ 577 nm
• 00813125014513 - Eye Safety Filter, Two-Position (532 nm): 2024-10-30 For use on the Leica or Wild Dovetails OD3 @ 532 nm
• 00813125014520 - Eye Safety Filter, Two-Position (532 nm): 2024-10-30 For use on the Zeiss Dovetails OD3 @ 532 nm