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FDA 510(k)

HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens

K-Number: K200618 · 2020-12-07

Decision Date2020-12-07
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Visco Vision, Inc.. It received FDA 510(k) clearance on 2020-12-07 under 510(k) number K200618. 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 HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens?

HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens is a medical device that received FDA 510(k) clearance on 2020-12-07. The listed applicant is Visco Vision, Inc.. The 510(k) number is K200618.

When did HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens receive FDA 510(k) clearance?

HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens received FDA 510(k) clearance on 2020-12-07, under 510(k) number K200618.

Who is the listed applicant for HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens?

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

What is the FDA product code for HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens?

The FDA product code for HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens 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 Visco Vision, 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 10 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

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