Clearance Summary
CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS received FDA 510(k) clearance under submission number K022373, sponsored by Cantor & Nissel , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2002-10-07.
- Submission: K022373
- Applicant / Sponsor: Cantor & Nissel , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5844
- Decision date: 2002-10-07
Classification & Regulation
This clearance is catalogued under FDA product code NJH and 21 CFR 886.5844, within the Ophthalmic review panel as a Class I device.