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 ID | 04260308240102 |
| NIH Device Record Key | 5685ccfd-7eba-4879-a501-e38a1eecd187 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BF-RhodoLED |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260308240102 [Primary] |
FDA Product Code
| MYH | System,Non-Coherent Light,Photodynamic Therapy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-23 |
| Device Publish Date | 2019-09-13 |
Devices Manufactured by Biofrontera Pharma GmbH
| 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 | 2019-09-23BF-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-RhodoLED | 2019-09-23 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 79111892 4296862 Live/Registered |
Biofrontera Pharma GmbH 2012-02-16 |
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