Iridex 577 Laser

GUDID 00813125015381

The Iridex® 577 (577 nm, true-yellow) Laser Console is a solid-state laser that is used to deliver laser energy in Continuous-Wave and MicroPulse® modes for ophthalmic applications.

IRIDEX CORPORATION

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• Primary Device ID: 00813125015381
• NIH Device Record Key: 422c9ee3-fbf5-4c9a-b653-3ebdd64501b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Iridex 577 Laser
• Version Model Number: 24000
• 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: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com
• Phone: (800) 388-4747
• Email: customerservice@iridex.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813125015381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230228

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: 2024-01-26
• Device Publish Date: 2024-01-18

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• 00813125016975 - SLA EasyView™ (577 nm): 2024-05-14 for Haag Streit 900 BM/BQ Slit Lamp
• 00813125016999 - SLA (577 nm): 2024-05-14 for Zeiss 30 slit lamp or equivalent
• 00813125017019 - SLA (532 nm): 2024-05-14 for Zeiss 30 CSO or equivalent
• 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