MELAFIND is an AI-enabled medical device from STRATA SKIN SCIENCES, INC., listed by FDA (PMA, P090012) with a decision date of 2011-11-01. Review panel: General and Plastic Surgery.
| FDA submission number | P090012 |
|---|---|
| Pathway | PMA |
| Company | STRATA SKIN SCIENCES, INC. |
| Review panel (specialty) | General and Plastic Surgery |
| FDA decision date | 2011-11-01 |
| Product code | OYD |
| Classification | Optical Diagnostic Device For Melanoma Detection |
| Device class | 2 |
| Regulation number | 878.1820 |
| Review time (calendar days) | 881 |
Official FDA database record · FDA AI-enabled device list
All General and Plastic Surgery AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.