MelaFind® - P090012
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: MelaFind®
PMA Applicant: MELA Sciences, Inc.
Address: 50 South Buckhout Street, Suite 1, Irvington, NY 10533
Approval Date: November 1, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf9/p090012a.pdf
What is it? An optical imaging and analysis device used in the detection of melanoma among atypical skin lesions.
How does it work? The device uses light to image the skin through a layer of isopropyl alcohol to generate a positive or negative result based on predefined image analysis algorithms.
When is it used? The device is used when a dermatologist chooses to obtain additional information on atypical skin lesions for a decision to biopsy.
What will it accomplish? MelaFind will provide the dermatologist with additional information about atypical skin lesions. This additional information may help a dermatologist find additional melanomas that may not have been found without the use of the device.
When should it not be used? There are no contraindications.
Additional information: Summary of Safety and Effectiveness and labeling will be available online.