Norlase LEAF photocoagulator

GUDID 05700002165442

The Norlase LEAF Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty

Norlase ApS

Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system

• Primary Device ID: 05700002165442
• NIH Device Record Key: 9ed29a75-a133-4bba-aa4d-fa4d63b1f8d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Norlase LEAF photocoagulator
• Version Model Number: N005-9010-Z
• Company DUNS: 305483903
• Company Name: Norlase ApS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• 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	05700002165442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190083

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: 2023-12-14
• Device Publish Date: 2023-12-06

On-Brand Devices [Norlase LEAF photocoagulator]

• 05700002165411: The Norlase Leaf Photocoagulator is intended to be used in ophthalmic laser procedures including
• 05700002165442: The Norlase LEAF Photocoagulator is intended to be used in ophthalmic laser procedures including