Clearance Summary
handLITE (TN19S) received FDA 510(k) clearance under submission number K250224, sponsored by iSMART Developments, 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 2025-04-18.
- Submission: K250224
- Applicant / Sponsor: iSMART Developments, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2025-04-18
Classification & Regulation
This clearance is catalogued under FDA product code ONE and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.