Clearance Summary
iCare HOME2 received FDA 510(k) clearance under submission number K211355, sponsored by Icare Finland OY. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2022-01-25.
- Submission: K211355
- Applicant / Sponsor: Icare Finland OY
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 2022-01-25
Classification & Regulation
This clearance is catalogued under FDA product code HKY and 21 CFR 886.1930, within the Ophthalmic review panel as a Class II device.