Device |
optical diagnostic device for melanoma detection |
Definition |
Intended in the detection of melanoma and high grade lesions among atypical lesions in order to rule-out melanoma. |
Physical State |
Optical radiation. |
Technical Method |
Use of visible and infrared optical radiation to generate images of targeted atypical lesions. |
Target Area |
Atypical pigmented lesions |
Review Panel |
General & Plastic Surgery |
Product Code | OYD |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
Submission Type |
PMA
|
Device Class |
3
|
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 |