Clearance Summary
MEDILENS-CS CORNEAL SHIELD received FDA 510(k) clearance under submission number K915861, sponsored by Chiron Ophthalmics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1992-03-06.
- Submission: K915861
- Applicant / Sponsor: Chiron Ophthalmics
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4750
- Decision date: 1992-03-06
Classification & Regulation
This clearance is catalogued under FDA product code MOE and 21 CFR 886.4750, within the Ophthalmic review panel as a Class I device.