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.
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.
| Device | BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR |
| Classification Name | System, Laser, Photodynamic Therapy |
| Generic Name | System, Laser, Photodynamic Therapy |
| Applicant | DUSA PHARMACEUTICALS, INC. |
| Date Received | 1999-03-16 |
| Decision Date | 1999-12-03 |
| Notice Date | 2000-11-14 |
| PMA | P990019 |
| Supplement | S |
| Product Code | MVF |
| Docket Number | 00M-1613 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | DUSA PHARMACEUTICALS, INC. 25 Upton Dr. wilmington, MA 01887 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990019 | Original Filing | |
| S007 | 2011-06-27 | Real-time Process |
| S006 | 2008-12-10 | 30-day Notice |
| S005 | 2007-10-30 | Normal 180 Day Track No User Fee |
| S004 | 2006-08-22 | 30-day Notice |
| S003 | 2005-03-03 | Normal 180 Day Track No User Fee |
| S002 | 2002-09-30 | Normal 180 Day Track |
| S001 | 2000-03-20 | Normal 180 Day Track |