Clearance Summary
Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) received FDA 510(k) clearance under submission number K161434, sponsored by Li-Tek Electronics Technologies. 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 2017-09-28.
- Submission: K161434
- Applicant / Sponsor: Li-Tek Electronics Technologies
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2017-09-28
Classification & Regulation
This clearance is catalogued under FDA product code OLP and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.