Clearance Summary
Konan Specular Microscope XVII received FDA 510(k) clearance under submission number K191558, sponsored by Konan Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2020-03-26.
- Submission: K191558
- Applicant / Sponsor: Konan Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 2020-03-26
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.