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 600 series dye modules (models 630 and 630 xp) and series 700 and 800 ktp/532 and ktp/yag (operating at 532 nm) surgical lasers
| Device | 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS |
| Generic Name | System, Laser, Photodynamic Therapy |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. |
| Date Received | 1994-04-13 |
| Decision Date | 1995-12-27 |
| PMA | P940012 |
| Supplement | S |
| Product Code | MVF |
| Docket Number | 97M-0204 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | AMERICAN MEDICAL SYSTEMS, INC. 10700 Bren Road West minnetonka, MN 55343 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940012 | Original Filing | |
| S002 | 1998-03-24 | Normal 180 Day Track |
| S001 | 1997-02-11 | Normal 180 Day Track |