iLumin 205000

GUDID 00893872001608

Optical Light Source: Fiberoptic Illuminator, Gen 2 iLumin series of revisions

Nova Eye, Inc.

Ophthalmic procedural light source unit

• Primary Device ID: 00893872001608
• NIH Device Record Key: 1d27262f-f054-42bf-a38a-4fbbb67021b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLumin
• Version Model Number: FI-200
• Catalog Number: 205000
• Company DUNS: 079755637
• Company Name: Nova Eye, Inc.
• 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: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893872001608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062259

FDA Product Code

• MPA: Endoilluminator

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: 2024-07-29
• Device Publish Date: 2024-07-19

Devices Manufactured by Nova Eye, Inc.

• 00893872001608 - iLumin: 2024-07-29Optical Light Source: Fiberoptic Illuminator, Gen 2 iLumin series of revisions
• 00893872001608 - iLumin: 2024-07-29 Optical Light Source: Fiberoptic Illuminator, Gen 2 iLumin series of revisions
• 00893872001622 - iTrack Advance: 2023-04-12 Canaloplasty Microcatheter Kit with Advanced Delivery System Kit Contents (1) Canaloplasty Microcatheter with Delivery System (2
• 893872001462 - iCAP Imaging Cap: 2020-12-08 Imaging Cap
• 00893872001585 - ViscoInjector: 2020-12-08 Opthalmic Viscoelastic Injector