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FDA 510(k)

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System

K-Number: K210300 · 2021-04-01

ApplicantVuesonic, LLC
Decision Date2021-04-01
Product CodeLYL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System is the device name listed in this FDA 510(k) record. The listed applicant is Vuesonic, LLC. It received FDA 510(k) clearance on 2021-04-01 under 510(k) number K210300. The device is classified under product code LYL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System?

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System is a medical device that received FDA 510(k) clearance on 2021-04-01. The listed applicant is Vuesonic, LLC. The 510(k) number is K210300.

When did VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System receive FDA 510(k) clearance?

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System received FDA 510(k) clearance on 2021-04-01, under 510(k) number K210300.

Who is the listed applicant for VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System?

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

What is the FDA product code for VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System?

The FDA product code for VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System is LYL.

Related Devices (Code: LYL)

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.

K2113613N Contact Lenses Adjunct CleanerSuzhou 3N Biological Technology Co., Ltd.

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.

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