Clearance Summary
EM-4000 Specular Microscope received FDA 510(k) clearance under submission number K171313, sponsored by Tomey Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2018-01-19.
- Submission: K171313
- Applicant / Sponsor: Tomey Corporation
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 2018-01-19
Classification & Regulation
This clearance is catalogued under FDA product code NQE and 21 CFR 886.1850, within the Ophthalmic review panel as a Class II device.