# ORE: FDA product code

- Device class: —; regulation: 21 CFR —
- FDA decisions: 1
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)

## Most-cited predicates
- K240226: Pixie Skin Tag (2024), cited by 1

Source page: https://510kreport.com/product-code/ORE
Data by year (CSV): https://510kreport.com/product-code/ORE.csv