Identity
- Trade Name
- MELAFIND FDA PMA
- Generic Name
- Optical diagnostic device for melanoma detection FDA PMA
Identifiers
- PMA Number
- P090012 FDA PMA
- FDA Product Code
- OYD FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 878.1820 FDA PMA
- Regulation Number
- 878.1820 FDA PMA
- Advisory Committee
- General, Plastic Surgery FDA PMA
- FDA Decision
- APRL FDA PMA
MelaFind is an optical diagnostic device for melanoma detection, classified as an optical diagnostic device under FDA classification 2. It is designed to assist dermatologists in evaluating clinically atypical cutaneous pigmented lesions that may exhibit characteristics of melanoma, excluding those with a definitive clinical diagnosis of melanoma. The device provides additional information to aid in the decision-making process for biopsy, but is not intended to confirm a clinical diagnosis of melanoma.
MelaFind is intended for use on pigmented lesions with a diameter between 2 mm and 22 mm, accessible by the imager, and located on intact, non-ulcerated, non-bleeding skin, excluding special anatomical sites such as acral, palmar, plantar, mucosal, or subungual areas. It is supplied as a single-use device and requires trained dermatologists to operate after completing a specific training program. The device received FDA PMA approval (P090012) and is regulated under FDA regulation number 878.1820.
Frequently asked questions
What types of skin lesions is MelaFind designed to evaluate, and what size range does it support?
MelaFind is specifically designed to assist dermatologists in evaluating clinically atypical pigmented lesions that may exhibit characteristics of melanoma, excluding those with a definitive clinical diagnosis of melanoma. It is intended for lesions with a diameter between 2 mm and 22 mm, provided they are accessible by the imager, pigmented, intact (non-ulcerated/non-bleeding), and not located on special anatomical sites like acral, palmar, plantar, mucosal, or subungual areas. The device is not meant for non-pigmented or skin-colored lesions.
Is MelaFind a reusable device, or is it intended for single-use only? How does this affect its clinical workflow?
MelaFind is supplied as a single-use device, meaning each unit is designed for one procedure only. This ensures sterility and reduces the risk of cross-contamination between patients. Clinicians must use a new device for each lesion evaluation, which simplifies workflow by eliminating the need for cleaning or reprocessing between uses, though it does require inventory management to maintain availability.
Who is authorized to operate MelaFind, and what training is required before use?
MelaFind is intended exclusively for use by trained dermatologists who have completed the manufacturer’s specific training program on its clinical diagnosis and management of skin cancer. The device is not intended for general practitioners or non-specialists, as its results are meant to supplement—not replace—the clinician’s clinical judgment. Training ensures proper interpretation of findings and adherence to the device’s intended use.
What anatomical areas or lesion characteristics would make a lesion ineligible for evaluation with MelaFind?
MelaFind is not suitable for lesions on special anatomical sites like acral (hands/feet), palmar, plantar, mucosal, or subungual areas. Additionally, it cannot be used on lesions that are non-pigmented, ulcerated, bleeding, scarred, contain foreign matter, or are located within 1 cm of the eye. Lesions outside the 2 mm to 22 mm diameter range or those with prior trauma/fibrosis are also excluded, as these factors may affect imaging accuracy or safety.
How does MelaFind’s output influence clinical decision-making, and what should clinicians consider alongside its results?
MelaFind provides additional information to aid dermatologists in deciding whether to biopsy a lesion, but its results are one element of the overall clinical assessment. A positive result (which may include melanoma, melanoma in situ, or high-grade dysplasia) should prompt consideration for biopsy, while a negative result does not rule out melanoma—clinicians must rely on the full clinical context (e.g., patient history, lesion characteristics) to guide further action. Non-evaluable lesions require careful re-evaluation for biopsy.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P090012 | Class II | Active |
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Manufacturer
- Manufacturer
- Strata Skin Sciences, inc.
Sources (1)
- FDA PMA P090012 24 fields · synced Sep 18, 2026