Clearance Summary
THE OCUPLOT D received FDA 510(k) clearance under submission number K822415, sponsored by Coherent Medical Division. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1982-09-07.
- Submission: K822415
- Applicant / Sponsor: Coherent Medical Division
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1360
- Decision date: 1982-09-07
Classification & Regulation
This clearance is catalogued under FDA product code HPJ and 21 CFR 886.1360, within the Ophthalmic review panel as a Class II device.