| Device |
optical diagnostic device for melanoma detection |
| Definition |
An optical diagnostic device for melanoma detection is a prescription device that measures and analyzes optical properties of a skin lesion. The device is intended for use by a physician trained in the clinical diagnosis and management of skin cancer as an adjunctive device following identification of a suspicious skin lesion. The output given by the device is intended to be used in combination with clinical and historical signs of skin cancer to obtain additional information prior to a decision to biopsy. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis. Please reference https://www.federalregister.gov/documents/2026/03/25/2026-05772/general-and-plastic-surgery-devices-reclassification-of-optical-diagnostic-devices-for-melanoma. |
| Physical State |
Optical measurement device and software algorithm |
| Technical Method |
An optical signal or spectrum is captured from a targeted skin lesion and analyzed by a software algorithm |
| Target Area |
Skin Lesion |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | OYD |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.1820
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
