Clearance Summary
SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE received FDA 510(k) clearance under submission number K981665, sponsored by Bio-Medical Sciences, 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 1998-12-07.
- Submission: K981665
- Applicant / Sponsor: Bio-Medical Sciences, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1350
- Decision date: 1998-12-07
Classification & Regulation
This clearance is catalogued under FDA product code MMQ and 21 CFR 886.1350, within the Ophthalmic review panel as a Class I device.