Clearance Summary
MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR received FDA 510(k) clearance under submission number K900091, sponsored by Onufryk Low Vision Ent.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1990-04-04.
- Submission: K900091
- Applicant / Sponsor: Onufryk Low Vision Ent.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5844
- Decision date: 1990-04-04
Classification & Regulation
This clearance is catalogued under FDA product code HQG and 21 CFR 886.5844, within the Ophthalmic review panel as a Class I device.