RhodoLED® XL

GUDID 04260308240164

Skin photodynamic therapy lamp

Primary Device ID	04260308240164
NIH Device Record Key	6ef95fcb-8ee0-4002-92ff-6d5dac43161d
Commercial Distribution Status	In Commercial Distribution
Brand Name	RhodoLED® XL
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

Device Issuing Agency	Device ID
GS1	04260308240164 [Primary]

MYH	System,Non-Coherent Light,Photodynamic Therapy

Steralize Prior To Use	false
Device Is Sterile	false

04260308240164 - RhodoLED® XL	2024-07-02RhodoLED® XL 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.
04260308240164 - RhodoLED® XL	2024-07-02 RhodoLED® XL is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydro
04260308240102 - BF-RhodoLED	2019-09-23 BF-RhodoLED® is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydro

Mark Image Registration \| Serial	Company Trademark Application Date
RHODOLED 79110915 4290690 Live/Registered	Biofrontera Pharma GmbH 2012-02-16