Clearance Summary
droplet® personal lancets received FDA 510(k) clearance under submission number K250016, sponsored by Htl-Strefa S.A. 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 2025-07-01.
- Submission: K250016
- Applicant / Sponsor: Htl-Strefa S.A
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4850
- Decision date: 2025-07-01
Classification & Regulation
This clearance is catalogued under FDA product code QRK and 21 CFR 878.4850, within the General, Plastic Surgery review panel as a Class II device.