# OUB: Instrument For Treatment Of Hyperhidrosis

- Device class: 2; regulation: 21 CFR 878.4400; FDA's rule: 510(k) required
- FDA decisions: 3
- Recalls: 2 (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)
- 2011: 1
- 2013: 1
- 2015: 1

## Most-cited predicates
- K103014: Miradry System (2011), cited by 2
- K131162: Miradry System (2013), cited by 1
- K150419: miraDry System MD4000 (2015), cited by 1

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