Clearance Summary
LOW VISION ENHANCEMENT SYSTEM (LVES) received FDA 510(k) clearance under submission number K910124, sponsored by Triangle Investments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1991-04-10.
- Submission: K910124
- Applicant / Sponsor: Triangle Investments
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5900
- Decision date: 1991-04-10
Classification & Regulation
This clearance is catalogued under FDA product code HPG and 21 CFR 886.5900, within the Ophthalmic review panel as a Class I device.