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 ID04260308240102
NIH Device Record Key5685ccfd-7eba-4879-a501-e38a1eecd187
Commercial Distribution StatusIn Commercial Distribution
Brand NameBF-RhodoLED
Version Model NumberUS
Company DUNS332358501
Company NameBiofrontera Pharma GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com
Phone781-245-1325
Emailinfo-us@biofrontera.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104260308240102 [Primary]

FDA Product Code

MYHSystem,Non-Coherent Light,Photodynamic Therapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-23
Device Publish Date2019-09-13

Devices Manufactured by Biofrontera Pharma GmbH

04260308240164 - RhodoLED® XL2024-07-02 RhodoLED® XL is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydro
04260308240102 - BF-RhodoLED2019-09-23BF-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.
04260308240102 - BF-RhodoLED2019-09-23 BF-RhodoLED® is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydro

Trademark Results [BF-RhodoLED]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BF-RHODOLED
BF-RHODOLED
79111892 4296862 Live/Registered
Biofrontera Pharma GmbH
2012-02-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.