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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameoptical diagnostic device for melanoma detection
Generic Nameoptical diagnostic device for melanoma detection
100 lakeside dr ste 100
horsham, PA 19044
PMA NumberP090012
Date Received06/03/2009
Decision Date11/01/2011
Product Code
OYD[ Registered Establishments with OYD ]
Docket Number 12M-0074
Notice Date 01/24/2012
Advisory Committee General & Plastic Surgery
Clinical Trials NCT00434057
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the melafind device. Melafind is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of melanoma or likely melanoma. Melafind is designed to be used when a dermatologist chooses to obtain additional information for a decision to biopsy. Melafind should not be used to confirm a clinical diagnosis of melanoma. Melafind is only for use by physicians trained in the clinical diagnosis and management of skin cancer (i. E. , dermatologists) who have also successfully completed a training program in the appropriate use of melafind. The melafind result is one element of the overall clinical assessment. Melafind positive lesions (which may include malignant melanoma, melanoma in situ, high grade dysplastic nevi and atypical melanocytic proliferation/hyper-plasia) should be considered for biopsy; the biopsydecision of a melafind negative lesion should be based on the remainder of the entire clinical context. Lesions that are "non-evaluable" by melafind should be carefully re-evaluated for biopsy. Melafind is indicated only for use on lesions with a diameter between 2 mm and 22 mm, lesions that are accessible by the melafind imager, lesions that are sufficiently pigmented (i. E. Not for use on non-pigmented or skin-colored lesions), lesions that do not contain a scar orfibrosis consistent with previous trauma, lesions where the skin is intact (le. , non-ulcerated or non-bleeding lesions), lesions greater than 1 cm away from the eye, lesions which do not contain foreign matter, and lesions not on special anatomic sites (ie. , not for use on acral,palmar, plantar, mucosal, or subungual areas). Melafind is not designed to detect pigmented non-melanoma skin cancers, so the dermatologist should rely on clinical experience to diagnose such lesions.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011