Clearance Summary
LDE4 Lancing Device received FDA 510(k) clearance under submission number K222656, sponsored by I-Sens, Inc.. 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 2022-11-23.
- Submission: K222656
- Applicant / Sponsor: I-Sens, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4850
- Decision date: 2022-11-23
Classification & Regulation
This clearance is catalogued under FDA product code QRL and 21 CFR 878.4850, within the General, Plastic Surgery review panel as a Class II device.