PMA P010061
- Device
- CURELIGHT BROADBAND (MODEL CURELIGHT 01)
- Applicant
- Photocure Asa
- PMA number
- P010061
- Product code
- MYH
- Decision date
- 2004-07-28
- Classification
- General, Plastic Surgery
- Generic name
- System, non-coherent light, photodynamic therapy
- 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.
Current openFDA PMA Record#
- Device
- CURELIGHT BROADBAND (MODEL CURELIGHT 01)
- Applicant
- Photocure Asa
- PMA number
- P010061
- Product code
- MYH
- Generic name
- System, non-coherent light, photodynamic therapy
- Decision date
- 2004-07-28
- Decision code
- APWD
- Date received
- 2001-09-27
- 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.