Clearance Summary
THE INTUITIVE COLORIMETER received FDA 510(k) clearance under submission number K012298, sponsored by Cerium Optical Technologies, 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 2001-09-26.
- Submission: K012298
- Applicant / Sponsor: Cerium Optical Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1160
- Decision date: 2001-09-26
Classification & Regulation
This clearance is catalogued under FDA product code NFD and 21 CFR 886.1160, within the Ophthalmic review panel as a Class I device.