FDA 510(k)
FDA class 2
Unknown
🇮🇱 Israel
ToothWave
K Number: DEN190039
·
Decision Sep 17, 2020
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
15
Review Days
392
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Basic Information
- Device Name
- ToothWave
- K Number
- DEN190039
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 872.6866
- Medical Specialty
- Dental
- Decision
- Unknown
- Applicant
- Home Skinovations , Ltd.
- Date Received
- August 22, 2019
- Decision Date
- September 17, 2020
- Product Code
- QMJ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QMJ | Powered Radiofrequency Toothbrush | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QMJ), ordered by most recent decision date.
View allOther Clearances by Home Skinovations , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K214078 | Silkn Toothwave | Jan 13, 2023 | Substantially Equivalent |
| K180279 | Silk'n MODEL H5003 device | May 9, 2018 | Substantially Equivalent |
| K171433 | Silk'n Infinity | Aug 11, 2017 | Substantially Equivalent |
| K162784 | Silk'n HST | Mar 25, 2017 | Substantially Equivalent |
| K152087 | HeatLux Pro II | Jul 29, 2016 | Substantially Equivalent |
| K150175 | HeatLux Pro I | Mar 31, 2015 | Substantially Equivalent |
| K141242 | GLIDE DEVICE | Oct 17, 2014 | Substantially Equivalent |
| K131870 | GLIDE DEVICE | Aug 14, 2013 | Substantially Equivalent |
| K121435 | SILKN BLUE | Feb 22, 2013 | Substantially Equivalent |
| K120582 | HEATLUX | Jul 6, 2012 | Substantially Equivalent |