Clearance Summary
KOI BLUE FIELD ENTOPTOSCOPE received FDA 510(k) clearance under submission number K812764, sponsored by Koi, 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 1981-12-02.
- Submission: K812764
- Applicant / Sponsor: Koi, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1780
- Decision date: 1981-12-02
Classification & Regulation
This clearance is catalogued under FDA product code HKL and 21 CFR 886.1780, within the Ophthalmic review panel as a Class II device.