Clearance Summary
BeneLife Premium Facial Treatment Pack, Model: QZ0701A received FDA 510(k) clearance under submission number K171647, sponsored by Infinitus (China) Company , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2017-10-23.
- Submission: K171647
- Applicant / Sponsor: Infinitus (China) Company , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2017-10-23
Classification & Regulation
This clearance is catalogued under FDA product code NFO and 21 CFR 882.5890, within the Neurology review panel as a Class II device.