LIO Plus Large Spot (810 nm)

GUDID 00813125016937

IRIDEX CORPORATION

Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope

• Primary Device ID: 00813125016937
• NIH Device Record Key: 8b86f574-6609-41c0-847a-833adb3de091
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIO Plus Large Spot (810 nm)
• Version Model Number: 13153-H500
• 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: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813125016937 [Primary]

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: 2024-04-04
• Device Publish Date: 2024-03-27

Devices Manufactured by IRIDEX CORPORATION

• 00813125016920 - LIO Plus (810 nm): 2024-04-04
• 00813125016937 - LIO Plus Large Spot (810 nm): 2024-04-04
• 00813125016937 - LIO Plus Large Spot (810 nm): 2024-04-04
• 00813125016944 - LIO Plus (532 nm): 2024-04-04
• 00813125016951 - LIO Plus (532 nm & 810 nm): 2024-04-04
• 00813125016968 - LIO Plus (577 nm): 2024-04-04
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• 00813125015282 - TxCell for IQ577, Iridex Z 30 & CSO980: 2022-08-09 TxCell Scanning Laser Delivery System for IQ577, Iridex Z 30 & CSO980 (without prism)