AccessGUDID - DEVICE: RhodoLED® XL (04260308240164)

GUDID

Device Identifier (DI) Information

Brand Name: RhodoLED® XL
Version or Model: US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Biofrontera Pharma GmbH

Primary DI Number: 04260308240164
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332358501 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59739	Skin photodynamic therapy lamp	A mobile, mains electricity (AC-powered) lamp intended to emit red light of high stability with a narrow spectrum (e.g., 630nm) for photodynamic therapy (PDT) applications on multiple anatomical sites (e.g., face, torso), to treat skin disorders such as non-melanoma skin cancer, non-cancerous skin lesions and/or ulcers. It is designed to selectively activate a photosensitizing agent at the specific anatomical site requiring treatment, thus providing anatomically specific PDT. This device is intended to be used by a healthcare professional in a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYH	System,Non-Coherent Light,Photodynamic Therapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ef95fcb-8ee0-4002-92ff-6d5dac43161d
Public Version Date: January 31, 2025
Public Version Number: 2
DI Record Publish Date: June 24, 2024