Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CHROMAGEN V3.0 READING AID SOFT CONTACT LENS

K-Number: K012132 · 2002-05-09

ApplicantCantor & Nissel , Ltd.
Decision Date2002-05-09
Product CodeNIC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CHROMAGEN V3.0 READING AID SOFT CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Cantor & Nissel , Ltd.. It received FDA 510(k) clearance on 2002-05-09 under 510(k) number K012132. The device is classified under product code NIC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHROMAGEN V3.0 READING AID SOFT CONTACT LENS?

CHROMAGEN V3.0 READING AID SOFT CONTACT LENS is a medical device that received FDA 510(k) clearance on 2002-05-09. The listed applicant is Cantor & Nissel , Ltd.. The 510(k) number is K012132.

When did CHROMAGEN V3.0 READING AID SOFT CONTACT LENS receive FDA 510(k) clearance?

CHROMAGEN V3.0 READING AID SOFT CONTACT LENS received FDA 510(k) clearance on 2002-05-09, under 510(k) number K012132.

Who is the listed applicant for CHROMAGEN V3.0 READING AID SOFT CONTACT LENS?

The FDA 510(k) record lists Cantor & Nissel , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHROMAGEN V3.0 READING AID SOFT CONTACT LENS?

The FDA product code for CHROMAGEN V3.0 READING AID SOFT CONTACT LENS is NIC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cantor & Nissel , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K041700CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEARK022373CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑