Assy Illumination Adapter PHOTON

GUDID 00813125010928

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: 00813125010928
• NIH Device Record Key: f51601cd-0021-4c5d-a0bd-0555da75d166
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assy Illumination Adapter PHOTON
• Version Model Number: 15653
• 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	00813125010928 [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

• 00813125010935 - SLA (810 nm): 2024-05-10 SLA, 810 nm, for Haag Streit w/MM Slit Lamp
• 00813125011147 - SLA EasyFit™ (532 nm): 2024-05-10 SLA EasyFit™, 532nm, for Zeiss 30 & Split-Mirror Slit Lamp
• 00813125011185 - SLA 50 µm (532 nm): 2024-05-10 SLA 50 µm, 532nm, for Haag Streit 900 BQ w/MM Slit Lamp
• 00813125011208 - SLA 50 µm (532 nm): 2024-05-10 SLA 50 µm, 532 nm, for Haag Streit 900BQ Slit Lamp
• 00813125016524 - SLA EasyView™ (532 nm): 2024-05-10 SLA EasyView™ , 532 nm, for Haag Streit BM/BQ CSO Slit Lamp
• 00813125016548 - SLA (810 nm): 2024-05-10 SLA, 810 nm, for Haag Streit 900 BM Slit Lamp
• 00813125016982 - SLA Standard (577 nm): 2024-05-10 for Haag Streit 900 BM/BQ Slit Lamp or equivalent
• 00813125017002 - SLA Standard (532 nm): 2024-05-10 for Haag Streit BM/BQ CSO or equivalent