Clearance Summary
COLOR OPTIC CORNEAL EYE SHIELD received FDA 510(k) clearance under submission number K843961, sponsored by Colors IN Optics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1984-11-28.
- Submission: K843961
- Applicant / Sponsor: Colors IN Optics , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4750
- Decision date: 1984-11-28
Classification & Regulation
This clearance is catalogued under FDA product code HOY and 21 CFR 886.4750, within the Ophthalmic review panel as a Class I device.