Clearance Summary
DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets received FDA 510(k) clearance under submission number K220643, 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 2022-07-08.
- Submission: K220643
- 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: 2022-07-08
Classification & Regulation
This clearance is catalogued under FDA product code FMK and 21 CFR 878.4850, within the General, Plastic Surgery review panel as a Class II device.