Clearance Summary
MENTOR HORIZON LOW VISION MAGNIFIER received FDA 510(k) clearance under submission number K915340, sponsored by Mentor O & O, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1992-03-30.
- Submission: K915340
- Applicant / Sponsor: Mentor O & O, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5820
- Decision date: 1992-03-30
Classification & Regulation
This clearance is catalogued under FDA product code HJG and 21 CFR 886.5820, within the Ophthalmic review panel as a Class I device.