Clearance Summary
MODEL 2000 INTRAOPERATIVE CORNEASCOPE received FDA 510(k) clearance under submission number K901009, sponsored by Kera Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1990-05-30.
- Submission: K901009
- Applicant / Sponsor: Kera Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1350
- Decision date: 1990-05-30
Classification & Regulation
This clearance is catalogued under FDA product code HLQ and 21 CFR 886.1350, within the Ophthalmic review panel as a Class I device.