# K214078: Silk’n Toothwave

- Pathway: 510(k) (Traditional)
- Applicant: Home Skinovations, Ltd.
- Decided: Jan 13, 2023 after 382 days
- Product code: QMJ (Powered Radiofrequency Toothbrush)
- Device class: 2
- Regulation: 21 CFR 872.6866
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN190039 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN190039: ToothWave™, Home Skinovations, Ltd. (2020) Summary page 5.

## Indications for use
The Silk’n Toothwave is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque, and the prevention and treatment of gingivitis. The Silk’n Toothwave is intended for over-the-counter use.

Source page: https://510kreport.com/device/K214078
Methodology: https://510kreport.com/methodology