Clearance Summary
OPTIM-EYES 450 received FDA 510(k) clearance under submission number K971875, sponsored by Taylor/Fox Enterprises, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1997-06-13.
- Submission: K971875
- Applicant / Sponsor: Taylor/Fox Enterprises, LLC
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1997-06-13
Classification & Regulation
This clearance is catalogued under FDA product code HQY and 21 CFR 886.5850, within the Ophthalmic review panel as a Class I device.