Clearance Summary
ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) received FDA 510(k) clearance under submission number K912740, sponsored by Visionary 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 1991-12-30.
- Submission: K912740
- Applicant / Sponsor: Visionary Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1350
- Decision date: 1991-12-30
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.