Cyclo G6 Laser Console

GUDID 00813125016555

IRIDEX CORPORATION

General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system

• Primary Device ID: 00813125016555
• NIH Device Record Key: a4afb096-3024-48fe-bf5b-1d30da0c0284
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cyclo G6 Laser Console
• Version Model Number: 66245-1
• 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	00813125016555 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2022-02-24
• Device Publish Date: 2022-02-16

On-Brand Devices [Cyclo G6 Laser Console]

• 00813125015374: 66245
• 00813125016555: 66245-1