Silk’n Toothwave
FDA 510(k) clearance K214078 · decided 2023-01-13
Clearance details
- K-number
- K214078
- Device name
- Silk’n Toothwave
- Applicant
- Home Skinovations , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-27
- Decision date
- 2023-01-13
- Days to decision
- 382 days
- Clearance type
- Traditional
- Product code
- QMJ
- Device class
- 2
- Regulation number
- 872.6866
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Yokneam, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ToothWave™ (DEN190039) | Home Skinovations , Ltd. | 2020-09-17 |
Recalls involving this device
No recalls on record reference this clearance.