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)

Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens

K-Number: K162005 · 2016-12-08

Decision Date2016-12-08
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Acuity Polymers, Inc.. It received FDA 510(k) clearance on 2016-12-08 under 510(k) number K162005. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens?

Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens is a medical device that received FDA 510(k) clearance on 2016-12-08. The listed applicant is Acuity Polymers, Inc.. The 510(k) number is K162005.

When did Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens receive FDA 510(k) clearance?

Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens received FDA 510(k) clearance on 2016-12-08, under 510(k) number K162005.

Who is the listed applicant for Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens?

The FDA 510(k) record lists Acuity Polymers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens?

The FDA product code for Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens is HQD.

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.

Other records listing Acuity Polymers, Inc. 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.

View all 11 devices →

Related Devices (Code: HQD)

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.

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.