Assy Illumination Adapter Bright Star

GUDID 00813125014193

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: 00813125014193
• NIH Device Record Key: f53e4eb9-dbd5-43bc-8617-a8a8406b9ff5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assy Illumination Adapter Bright Star
• Version Model Number: 15683
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813125014193 [Primary]

FDA Product Code

• HQF: Laser, Ophthalmic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-03-24

Devices Manufactured by IRIDEX CORPORATION

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• 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)