Clearance Summary
Silk'n Titan Allways received FDA 510(k) clearance under submission number K230013, sponsored by Silk'N Beauty , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-08-30.
- Submission: K230013
- Applicant / Sponsor: Silk'N Beauty , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4420
- Decision date: 2023-08-30
Classification & Regulation
This clearance is catalogued under FDA product code PAY and 21 CFR 878.4420, within the General, Plastic Surgery review panel as a Class II device.