Product code MVF
- Device name
- System, Laser, Photodynamic Therapy
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P990019S009 | BLU-U Blue Light Photodynamic Therapy Illuminator | Sun Pharmaceutical Industries, Inc. | 2025-05-01 |
| P050026S003 | Quantel Activis Laser, Modulight ML6710i Laser and ML-SLA, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters | Bausch + Lomb Ireland Limited | 2025-02-11 |
| P050026S002 | Qcellus Laser, Activis Laser, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters | Bausch + Lomb Ireland Limited | 2023-01-20 |
| P990021S005 | PHOTOFRIN 630 PDT Laser | Pinnacle Biologics, Inc. | 2022-03-02 |
| P990021S004 | PHOTOFRIN 630 PDT Laser | Pinnacle Biologics, Inc. | 2018-01-17 |
| P990021S003 | PHOTOFRIN 630 PDT LASER | Pinnacle Biologics, Inc. | 2016-06-28 |
| P050026S001 | QCELLUS LASER | Bausch + Lomb Ireland Limited | 2013-09-26 |
| P990019S007 | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR | Sun Pharmaceutical Industries, Inc. | 2011-07-07 |
| P990021S002 | ANGIO DYNAMICS 630PDT LASER | Pinnacle Biologics, Inc. | 2010-10-13 |
| P990019S006 | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR | Sun Pharmaceutical Industries, Inc. | 2009-01-09 |
| P990048S003 | VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER | Carl Zeiss Meditec, AG | 2008-10-31 |
| P990019S005 | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170 | Sun Pharmaceutical Industries, Inc. | 2008-10-10 |
| P990019S004 | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR | Sun Pharmaceutical Industries, Inc. | 2006-09-21 |
| P050026 | QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS | Bausch + Lomb Ireland Limited | 2006-04-04 |
| P050021 | CERALAS I LASER | Biolitec, Inc. | 2005-12-20 |
| P990019S003 | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170 | Sun Pharmaceutical Industries, Inc. | 2005-10-06 |
| P990021S001 | DIOMED 630 PDT LASER | Pinnacle Biologics, Inc. | 2003-08-01 |
| P990019S002 | BLU-U | Sun Pharmaceutical Industries, Inc. | 2003-01-09 |
| P990049S001 | COHERENT OPAL PHOTOACTIVATOR | Lumenis | 2001-09-27 |
| P990048S001 | VISULAS 690S AND VISULINK PDT/U ADAPTER | Carl Zeiss Meditec, AG | 2001-09-27 |
| P990048S002 | VISULAS 690S LASER AND VISULINK PDT ADAPTER | Carl Zeiss Meditec, AG | 2001-07-03 |
| P990019S001 | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPHY ILLUMINATOR | Sun Pharmaceutical Industries, Inc. | 2000-09-26 |
| P990021 | DIOMED 630 PDT LASER | Pinnacle Biologics, Inc. | 2000-06-30 |
| P990049 | COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM | Lumenis | 2000-04-12 |
| P990048 | ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER | Carl Zeiss Meditec, AG | 2000-04-12 |
| P990019 | BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR | Sun Pharmaceutical Industries, Inc. | 1999-12-03 |
| P940012 | 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS | American Medical Systems, Inc. | 1995-12-27 |
| P940011 | COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS | Lumenis, Inc. | 1995-12-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06429810677020 | Modulight ML6710i Laser and ML-SLA | Modulight Oyj | 2023-08-01 |
| 00376128000193 | Photofrin® 630 PDT Laser | Pinnacle Biologics, Inc. | 2022-03-11 |
| 00376128000179 | Photofrin® 630 PDT Laser | Pinnacle Biologics, Inc. | 2018-02-13 |
| 00376128000155 | Photofrin® 630 PDT Laser | Pinnacle Biologics, Inc. | 2016-09-19 |
| M706417011 | BLU-U® Blue Light Photodynamic Therapy Illuminator | DUSA PHARMACEUTICALS INC. | 2014-09-15 |
| M706417021 | BLU-U® Blue Light Photodynamic Therapy Illuminator | DUSA PHARMACEUTICALS INC. | 2014-09-15 |
| M706417031 | BLU-U® Blue Light Photodynamic Therapy Illuminator | DUSA PHARMACEUTICALS INC. | 2014-09-15 |