510(k) · Cleared
ClearedSilk’n Toothwave
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Home Skinovations, Ltd. · QMJ Powered Radiofrequency Toothbrush
Cleared on Jan 13, 2023 as substantially equivalent to DEN190039 (Home Skinovations, Ltd., 2020) after a 382-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Jan 13, 2023
- Review
- 382 days
- Class
- Class II
- Product code
- QMJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN190039 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backDEN190039 ToothWave™Home Skinovations, Ltd. · 2020
- This deviceK214078 Silk’n ToothwaveHome Skinovations, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN190039 | ToothWave™ | Home Skinovations, Ltd. | 2020 | — |
| 0 (this device) | K214078 | Silk’n Toothwave | Home Skinovations, Ltd. | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QMJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN190039 | ToothWave™Summary page 5…s 510k application: Manufacturer Device 510(k) No. Home Skinovations Ltd. Silk’n Toothwave DEN190039 Device Description: The Silk’n Toothwave device (a.k.a Silk'n H7001 Powered Toothbrush) is a handheld, rechargeable, powered, r… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All QMJ devicesQMJ Powered Radiofrequency Toothbrush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QMJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QMJ
Too few QMJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QMJ
No recall names QMJ since 2007.
Adverse event reports per year · QMJ
No MAUDE report names QMJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K214078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214078: Silk’n Toothwave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214078
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026