CURELIGHT BROADBAND (MODEL CURELIGHT 01)
FDA premarket approval P010061 · decided 2004-07-28
Approval details
- PMA number
- P010061
- Trade name
- CURELIGHT BROADBAND (MODEL CURELIGHT 01)
- Generic name
- System, non-coherent light, photodynamic therapy
- Applicant
- Photocure Asa
- Date received
- 2001-09-27
- Decision date
- 2004-07-28
- Days to decision
- 1035 days
- Decision code
- APWD
- Product code
- MYH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Oslo
- 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.
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