← [Ophthalmic](/submissions/OP) · Product Code NCZ # NCZ · Lens, Contact, For Color Vision Deficiency _Ophthalmic · 21 CFR 886.5925 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NCZ ## Overview - **Product Code:** NCZ - **Device Name:** Lens, Contact, For Color Vision Deficiency - **Regulation:** 21 CFR 886.5925 - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) - **3rd-party reviewable:** yes ## Identification A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water. ## Classification Rationale (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear. ## Cleared Devices (1) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K994320](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NCZ/K994320.md) | CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES | Cantor & Silver , Ltd. | Oct 20, 2000 | SESE | ## Top Applicants - Cantor & Silver , Ltd. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NCZ](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NCZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NCZ