PMA P050021
- Device
- CERALAS I LASER
- Applicant
- Biolitec, Inc.
- PMA number
- P050021
- Product code
- MVF
- Decision date
- 2005-12-20
- Classification
- Radiology
- Generic name
- System, laser, photodynamic therapy
- Approval order statement
- APPROVAL FOR THE CERALAS I LASER SYSTEM AND CERALINK SLIT LAMP ADAPTER. THE DEVICE IS INDICATED FOR THE PHOTOACTIVATION OF THE LIGHT ACTIVATED DRUG VISUDYNE (VERTEPORFIN FOR INJECTION) IN PHOTODYNAMIC THERAPY FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO AGE-RELATED MACULAR DEGENERATION, PATHOLOGIC MYOPIA, OR PRESUMED OCULAR HISTOPLASMOSIS.
Current openFDA PMA Record#
- Device
- CERALAS I LASER
- Applicant
- Biolitec, Inc.
- PMA number
- P050021
- Product code
- MVF
- Generic name
- System, laser, photodynamic therapy
- Decision date
- 2005-12-20
- Decision code
- APWD
- Date received
- 2005-06-09
- Approval order statement
- APPROVAL FOR THE CERALAS I LASER SYSTEM AND CERALINK SLIT LAMP ADAPTER. THE DEVICE IS INDICATED FOR THE PHOTOACTIVATION OF THE LIGHT ACTIVATED DRUG VISUDYNE (VERTEPORFIN FOR INJECTION) IN PHOTODYNAMIC THERAPY FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO AGE-RELATED MACULAR DEGENERATION, PATHOLOGIC MYOPIA, OR PRESUMED OCULAR HISTOPLASMOSIS.