Clearance Summary
Silkn Toothwave received FDA 510(k) clearance under submission number K214078, sponsored by Home Skinovations , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-01-13.
- Submission: K214078
- Applicant / Sponsor: Home Skinovations , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6866
- Decision date: 2023-01-13
Classification & Regulation
This clearance is catalogued under FDA product code QMJ and 21 CFR 872.6866, within the Dental review panel as a Class II device.