Ceralas I Laser

FDA premarket approval P050021 · System, laser, photodynamic therapy

PMA numberP050021

Approval

Applicant
Biolitec, Inc.
Received
June 9, 2005
Decision date
December 20, 2005 (APWD)
Supplements
0
Product code
MVF – System, Laser, Photodynamic Therapy

Official FDA PMA record

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.