Clearance Summary
INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) received FDA 510(k) clearance under submission number K950077, sponsored by Par Vision Systems 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 1995-06-14.
- Submission: K950077
- Applicant / Sponsor: Par Vision Systems Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1350
- Decision date: 1995-06-14
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.