Norlase Leaf photocoagulator

GUDID 05700002165411

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

Norlase ApS

Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface

• Primary Device ID: 05700002165411
• NIH Device Record Key: f36a99ea-1cdc-41ac-8b31-283bf38623b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Norlase Leaf photocoagulator
• Version Model Number: N005-9010-03
• 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	05700002165411 [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: 2019-10-21
• Device Publish Date: 2019-10-12

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