|Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.|
|Device||BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR|
|Generic Name||system, laser, photodynamic therapy|
|Applicant||DUSA PHARMACEUTICALS, INC.|
25 upton dr.
wilmington, MA 01887
|Advisory Committee||General & Plastic Surgery|
|Expedited Review Granted?||No|
|Approval Order Statement |
The devices is indicated for use in Photodynamic Therapy with Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution, 20% for the treatment of non-hyperkeratotic actinic keratoses of the face or scalp.
|Approval Order||Approval Order|
|Summary||Summary of Safety and Effectiveness|
|Supplements:||S001 S002 S003 S004 S005 S006 S007|