TFX-LT2000 Therapy Light

GUDID 00086001245602

Light therapy device for onychomycosis

ToeFX Inc

Nail laser phototherapy unit

• Primary Device ID: 00086001245602
• NIH Device Record Key: 75a008d8-92db-4712-b67f-a9492f269e31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TFX-LT2000 Therapy Light
• Version Model Number: TFX-LT2000
• Company DUNS: 202099070
• Company Name: ToeFX Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00086001245602 [Primary]

FDA Product Code

• PDZ: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

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: 2024-11-25
• Device Publish Date: 2024-11-15