This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Ceralas I Laser and Ceralink Slit Lamp Adapter
PMA Applicant: QLT, Incorporated
Address: 887 Great Northern Way, Vancouver, British Columbia, Canada, V5T 4T5
Approval Date: December 20, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050021a.pdf
What is it? The Ceralas I Laser and Ceralink Slit Lamp Adapter is a diode laser system used to activate a light sensitive (photoactivated) drug called Visudyne. This therapy may help delay vision loss in patients with an eye disorder called subfoveal choroidal neovascularization (CNV). CNV is an irreversible eye disorder in which the abnormal growth of new blood vessels in the eye causes swelling and scar tissue that result in vision loss.
How does it work? The laser delivers a specific wavelength and energy to the target site in a patient’s retina through a combination of fiber optic delivery fibers, slit lamp optics, and magnifying lenses. The laser is used after Visudyne has been injected into the patient’s bloodstream.
When is it used? This combination of laser light and photoactivated drug is intended for the photodynamic therapy of patients who have predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis.
What will it accomplish? This treatment is intended to delay the eventual loss of vision in the affected eye. Clinical data has demonstrated that the photoactivation of Visudyne results in the collapse of the new blood vessels that gradually interfere with a patient’s vision.
When should it not be used? There are no known contraindications for the Ceralas I Laser or the Ceralink Slit Lamp Adapter for this indication for use. Refer to the drug package insert for any specific contraindications for the use of the drug Visudyne for these indications for use.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050021