TxCell for IQ532, Iridex Z 30 & CSO9800

GUDID 00813125015312

TxCell Scanning Laser Delivery System for IQ532, Iridex Z30 & CSO9800 (without prism)

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

• Primary Device ID: 00813125015312
• NIH Device Record Key: 3916ceb8-d2ad-426b-80b7-ad4ab641bd1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TxCell for IQ532, Iridex Z 30 & CSO9800
• Version Model Number: 70297
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813125015312 [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: 2022-08-09
• Device Publish Date: 2022-08-01

Devices Manufactured by IRIDEX CORPORATION

• 00813125016920 - LIO Plus (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
• 00813125015381 - Iridex 577 Laser: 2024-01-26 The Iridex® 577 (577 nm, true-yellow) Laser Console is a solid-state laser that is used to deliver laser energy in Continuous-W
• 00813125015473 - Iridex 532 Laser: 2024-01-26 The Iridex® 532 (532, green) Laser Console is a solid-state laser that is used to deliver laser energy in Continuous-Wave for e
• 00813125015282 - TxCell for IQ577, Iridex Z 30 & CSO980: 2022-08-09 TxCell Scanning Laser Delivery System for IQ577, Iridex Z 30 & CSO980 (without prism)