BLU-U Blue Light Photodynamic Therapy Illuminator Model 4170
by Sun Pharmaceutical Industries, Inc. FDA registration: United States PMA
PMA P990019 Product code MVF
Overview
This device is a System, Laser, Photodynamic Therapy designed for use in photodynamic therapy procedures. It emits blue light to activate aminolevulinic acid (ALA) in topical solutions, facilitating the treatment of non-hyperkeratotic actinic keratoses on the face or scalp.
The BLU-U Blue Light Photodynamic Therapy Illuminator Model 4170 is supplied as a reusable medical device and is intended for use in clinical settings. It has received FDA_PMA authorization under PMA number P990019, with a decision date of December 3, 1999. The device is classified under product code MVF and is regulated as a Class III medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP990019 | Date3 Dec 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Blu -U Blue Light Photodynamic Therapy Illuminator
- Generic Name
- System, laser, photodynamic therapy
- PMA Number
- FDA Product Code
- MVF
- Device Class
- Class III
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- APPR Approved
Other devices from Sun Pharmaceutical Industries, Inc.
Questions
What specific skin conditions is the BLU-U Blue Light Photodynamic Therapy Illuminator designed to treat?
The BLU-U is specifically designed for treating non-hyperkeratotic actinic keratoses on the face or scalp when used in conjunction with aminolevulinic acid (ALA) topical solutions like Levulan Kerastick. It activates the ALA to generate a phototoxic reaction that targets abnormal skin cells.
Is the BLU-U Blue Light Photodynamic Therapy Illuminator a single-use or reusable device?
The BLU-U is a reusable medical device, intended for use in clinical settings where multiple treatments may be performed. This design allows for cost-effective use across multiple procedures.
What regulatory pathway was followed for the approval of this device, and what is its classification?
The BLU-U received FDA authorization through a Premarket Approval (PMA) application, identified as PMA number P990019. It is classified as a Class III medical device under product code MVF, indicating it requires stringent regulatory oversight due to its intended use in photodynamic therapy.
What type of light does the BLU-U emit, and how does it interact with the treatment solution?
The BLU-U emits blue light, which activates aminolevulinic acid (ALA) in topical solutions like Levulan Kerastick. This activation creates a phototoxic effect that selectively targets and treats non-hyperkeratotic actinic keratoses on the face or scalp.
What is the intended clinical setting for use of the BLU-U Blue Light Photodynamic Therapy Illuminator?
The BLU-U is intended for use exclusively in clinical settings, where trained professionals can administer photodynamic therapy under controlled conditions. Its reusable design and specialized function make it unsuitable for home or non-professional use.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA PMA P990019