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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceCURELIGHT BROADBAND (MODEL CURELIGHT 01)
Generic NameSystem, non-coherent light, photodynamic therapy
ApplicantPhotocure Asa
Hoffsveien 48
Oslo N-037-0377
PMA NumberP010061
Date Received09/27/2001
Decision Date07/28/2004
Withdrawal Date08/28/2008
Product Code MYH 
Docket Number 04M-0345
Notice Date 08/04/2004
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE CURELIGHT BROADBAND (MODEL CURELIGHT 01). THE DEVICE IS INDICATED FOR USE IN COMBINATION WITH TRADENAME CREAM FOR TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF THE FACE AND SCALP IN IMMUNOCOMPETENT PATIENTS WHEN USED IN CONJUNCTION WITH LESION PREPARATION (DEBRIDEMENT USING A SHARP DERMAL CURETTE) IN THE PHYSICIAN'S OFFICE WHEN OTHER THERAPIES ARE UNACCEPTABLE OR CONSIDERED MEDICALLY LESS APPROPRIATE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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