OMA (810 nm)

GUDID 00813125010584

OMA, 810nm, for Zeiss Visu 150/200 Operating Microscope

IRIDEX CORPORATION

General/multiple surgical diode laser system

• Primary Device ID: 00813125010584
• NIH Device Record Key: fb2a1430-c686-4da8-965a-e8005e4dd51e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMA (810 nm)
• Version Model Number: 13411
• 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: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com
• Phone: 1-800-388-4747
• Email: techsupport@iridex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813125010584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020374

FDA Product Code

• HQF: Laser, Ophthalmic

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: 2024-05-14
• Device Publish Date: 2024-05-06

On-Brand Devices [OMA (810 nm)]

• 00813125010645: OMA, 810 nm, for OPMI-6 Operating Microscope
• 00813125010591: OMA, 810 nm, for Leica/Wild M650/M690 Operating Microscope
• 00813125010584: OMA, 810nm, for Zeiss Visu 150/200 Operating Microscope