FDA.reportPublic FDA data

RhodoLED® XL

Primary DI
04260308240164
Brand
RhodoLED® XL
Company
Biofrontera Pharma GmbH
Model
US
Device description
RhodoLED® 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.
Published
2024-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MYHSystem,Non-Coherent Light,Photodynamic Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYHSystem, Non-Coherent Light, Photodynamic TherapyUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260308240164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260308240164042603082401644260308240164

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-245-1325info@bfinc.com

Regulatory Flags#

DUNS number
332358501
Device count
1
Combination product
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260308240102BF-RhodoLEDUS2019-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262581550008BF-RhodoLEDBiofrontera Discovery GmbHMYH2026-10-16
04262581550015RhodoLED XLBiofrontera Discovery GmbHMYH2026-10-16
04262581550022RhodoLED XL-CBiofrontera Discovery GmbHMYH2026-10-16
04260308240102BF-RhodoLEDBiofrontera Pharma GmbHMYH2019-09-13