BF-RhodoLED

GUDID 04260308240102

BF-RhodoLED® is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydrochloride) gel, 10% for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.

Biofrontera Pharma GmbH

Skin photodynamic therapy lamp

• Primary Device ID: 04260308240102
• NIH Device Record Key: 5685ccfd-7eba-4879-a501-e38a1eecd187
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BF-RhodoLED
• Version Model Number: US
• Company DUNS: 332358501
• Company Name: Biofrontera Pharma GmbH
• 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: true
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• 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: 781-245-1325
• Email: info-us@biofrontera.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260308240102 [Primary]

FDA Product Code

• MYH: System,Non-Coherent Light,Photodynamic Therapy

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: 2019-09-23
• Device Publish Date: 2019-09-13