Clearance Summary
CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES received FDA 510(k) clearance under submission number K994320, sponsored by Cantor & Silver , 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 2000-10-20.
- Submission: K994320
- Applicant / Sponsor: Cantor & Silver , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2000-10-20
Classification & Regulation
This clearance is catalogued under FDA product code NCZ and 21 CFR 886.5925, within the Ophthalmic review panel as a Class II device.