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.
Approval for the coherent pld1 and pdl2 lambda plus photodynamic lasers
| Device | COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS |
| Generic Name | System, Laser, Photodynamic Therapy |
| Applicant | LUMENIS, INC. |
| Date Received | 1994-04-13 |
| Decision Date | 1995-12-27 |
| PMA | P940011 |
| Supplement | S |
| Product Code | MVF |
| Docket Number | 97M-0204 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LUMENIS, INC. 3959 West 1820 South salt Lake City, UT 84104 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940011 | Original Filing | |
| S003 | 1998-07-10 | Normal 180 Day Track |
| S002 | 1998-03-25 | Normal 180 Day Track |
| S001 | 1997-02-14 | Normal 180 Day Track |