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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceCERALAS I LASER
Generic NameSYSTEM, LASER, PHOTODYNAMIC THERAPY
ApplicantBIOLITEC, INC.
515 SHAKER RD.
EAST LONGMEADOW, MA 01028
PMA NumberP050021
Date Received06/09/2005
Decision Date12/20/2005
Withdrawal Date 10/20/2008
Product Code MVF 
Docket Number 06M-0161
Notice Date 04/18/2006
Advisory Committee Radiology
Expedited Review Granted? No
Combination ProductNo
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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