Clearance Summary
CORNEAL LIGHT SHIELD received FDA 510(k) clearance under submission number K850270, sponsored by Mentor O & O, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1985-05-31.
- Submission: K850270
- Applicant / Sponsor: Mentor O & O, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4700
- Decision date: 1985-05-31
Classification & Regulation
This clearance is catalogued under FDA product code HRM and 21 CFR 878.4700, within the General, Plastic Surgery review panel as a Class I device.