RhodoLED XL-C

Primary DI
04262581550022
Brand
RhodoLED XL-C
Company
Biofrontera Discovery GmbH
Model
BF-LED-XL-C
Device description
RhodoLED XL-C is a red light-emitting LED lamp, which is used exclusively in combination with Ameluz® gel for the treatment of lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp, and superficial basal cell carcinoma (sBCC).
Published
2026-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04262581550022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262581550022042625815500224262581550022

Contacts#

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

Regulatory Flags#

DUNS number
343946590
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04262581550008BF-RhodoLEDBF-LED-FV-US2026-10-16
04262581550015RhodoLED XLBF-LED-XL2026-10-16

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
04260308240164RhodoLED® XLBiofrontera Pharma GmbHMYH2024-06-24
04260308240102BF-RhodoLEDBiofrontera Pharma GmbHMYH2019-09-13