# KCW: Epilator, High Frequency, Needle-Type

- Device class: 1; regulation: 21 CFR 878.5350; FDA's rule: 510(k) exempt
- FDA decisions: 43
- 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)
- 1986: 3
- 1987: 2
- 1988: 6
- 1989: 2
- 1990: 2
- 1991: 1
- 1993: 3
- 1994: 4
- 1995: 3
- 1996: 1

## Most-cited predicates
- K881276: HR-5000 Electrosurgical Device for New Indications (1988), cited by 1
- K895687: D'plume Xxii Photocoagulator (Epilation Machine) (1990), cited by 1
- K954031: Compu-Blend Epilator (1996), cited by 1

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