Clearance Summary
3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM received FDA 510(k) clearance under submission number K083316, sponsored by Topcon Medical Systems, 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 2009-03-13.
- Submission: K083316
- Applicant / Sponsor: Topcon Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 2009-03-13
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.