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)

TETRAFILCON A HYDROPHILIC CONTACT LENSES

K-Number: K950968 · 1995-07-25

Decision Date1995-07-25
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TETRAFILCON A HYDROPHILIC CONTACT LENSES is the device name listed in this FDA 510(k) record. The listed applicant is CooperVision, Inc.. It received FDA 510(k) clearance on 1995-07-25 under 510(k) number K950968. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TETRAFILCON A HYDROPHILIC CONTACT LENSES?

TETRAFILCON A HYDROPHILIC CONTACT LENSES is a medical device that received FDA 510(k) clearance on 1995-07-25. The listed applicant is CooperVision, Inc.. The 510(k) number is K950968.

When did TETRAFILCON A HYDROPHILIC CONTACT LENSES receive FDA 510(k) clearance?

TETRAFILCON A HYDROPHILIC CONTACT LENSES received FDA 510(k) clearance on 1995-07-25, under 510(k) number K950968.

Who is the listed applicant for TETRAFILCON A HYDROPHILIC CONTACT LENSES?

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

What is the FDA product code for TETRAFILCON A HYDROPHILIC CONTACT LENSES?

The FDA product code for TETRAFILCON A HYDROPHILIC CONTACT LENSES is LPL.

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 CooperVision, 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 97 devices →

Related Devices (Code: LPL)

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.

↑