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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceCERALAS I LASER
Classification Namesystem, laser, photodynamic therapy
Generic Namesystem, laser, photodynamic therapy
Applicant
BIOLITEC, 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[ Registered Establishments with MVF ]
Docket Number 06M-0161
Notice Date 04/18/2006
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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