Clearance Summary
FORESEE HOME received FDA 510(k) clearance under submission number K091579, sponsored by Notal Vision , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2009-12-23.
- Submission: K091579
- Applicant / Sponsor: Notal Vision , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1605
- Decision date: 2009-12-23
Classification & Regulation
This clearance is catalogued under FDA product code HPT and 21 CFR 886.1605, within the Ophthalmic review panel as a Class I device.