Clearance Summary
OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 received FDA 510(k) clearance under submission number K092470, sponsored by Topcon Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2009-09-02.
- Submission: K092470
- Applicant / Sponsor: Topcon Corp.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 2009-09-02
Classification & Regulation
This clearance is catalogued under FDA product code OBO and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.