FDA 510(k)

Alcon (serafilcon A) soft contact lenses for daily wear

K-Number: K212806 · 2021-12-28

Decision Date2021-12-28

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Alcon (serafilcon A) soft contact lenses for daily wear is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2021-12-28 under 510(k) number K212806. 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 Alcon (serafilcon A) soft contact lenses for daily wear?

Alcon (serafilcon A) soft contact lenses for daily wear is a medical device that received FDA 510(k) clearance on 2021-12-28. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K212806.

When did Alcon (serafilcon A) soft contact lenses for daily wear receive FDA 510(k) clearance?

Alcon (serafilcon A) soft contact lenses for daily wear received FDA 510(k) clearance on 2021-12-28, under 510(k) number K212806.

Who is the listed applicant for Alcon (serafilcon A) soft contact lenses for daily wear?

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

What is the FDA product code for Alcon (serafilcon A) soft contact lenses for daily wear?

The FDA product code for Alcon (serafilcon A) soft contact lenses for daily wear is LPL.

Related Clinical Trials

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NCT04840563Surface Refractive Index Shift of Kalifilcon A Compared With Dailies Total1 and Precision1 LensesCOMPLETED NCT06611670Outcomes of High vs Physiological Intraocular Pressure During Cataract Surgery Using ACTIVE SENTRYCOMPLETED NCT06749496Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of WearCOMPLETED NCT06751225Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With AstigmatismCOMPLETED NCT07747311Contact Lenses to Slow Myopia Progression in AdultsNOT_YET_RECRUITING NCT05285527MiSight 1 Day Safety Post-Approval StudyACTIVE_NOT_RECRUITING

Other records listing Alcon Laboratories, Inc. as applicant

PMA P840064AID, SURGICAL, VISCOELASTIC PMA P930014intraocular lens PMA P190018intraocular lens PMA P010019Lenses, soft contact, extended wear PMA P220007Lenses, soft contact, extended wear K254052DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal

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Related Devices (Code: LPL)

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.