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Device | CURELIGHT BROADBAND (MODEL CURELIGHT 01) |
Generic Name | System, non-coherent light, photodynamic therapy |
Applicant | PHOTO CURE ASA HOFFSVEIEN 48 OSLO N-037-0377 |
PMA Number | P010061 |
Date Received | 09/27/2001 |
Decision Date | 07/28/2004 |
Withdrawal Date
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08/28/2008 |
Product Code |
MYH |
Docket Number | 04M-0345 |
Notice Date | 08/04/2004 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | Yes |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
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