Eagle

GUDID 07290018686027

The Eagle device is a Q-switched, 532 nm-wavelength, frequency-doubled Nd: YAG laser that is intended for use in performing selective laser trabeculoplasty.

BELKIN VISION LTD

Ophthalmic solid-state laser system

• Primary Device ID: 07290018686027
• NIH Device Record Key: 2c9c2bf6-c6f3-42f9-b7c1-44bc83196555
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eagle
• Version Model Number: 420840010
• Company DUNS: 600318341
• Company Name: BELKIN VISION LTD
• 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	07290018686027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230722

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: 2024-08-08
• Device Publish Date: 2024-07-31