Clearance Summary
LFR-260 received FDA 510(k) clearance under submission number K233295, sponsored by Evolution Optiks Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2024-05-31.
- Submission: K233295
- Applicant / Sponsor: Evolution Optiks Limited
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1770
- Decision date: 2024-05-31
Classification & Regulation
This clearance is catalogued under FDA product code SBI and 21 CFR 886.1770, within the Ophthalmic review panel as a Class I device.