FDA 510(k)

Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)

K-Number: K242059 · 2024-08-14

ApplicantX-Cel Specialty Contacts, A Walman Optical Company

Decision Date2024-08-14

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) is the device name listed in this FDA 510(k) record. The listed applicant is X-Cel Specialty Contacts, A Walman Optical Company. It received FDA 510(k) clearance on 2024-08-14 under 510(k) number K242059. 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 Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)?

Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) is a medical device that received FDA 510(k) clearance on 2024-08-14. The listed applicant is X-Cel Specialty Contacts, A Walman Optical Company. The 510(k) number is K242059.

When did Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) receive FDA 510(k) clearance?

Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) received FDA 510(k) clearance on 2024-08-14, under 510(k) number K242059.

Who is the listed applicant for Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)?

The FDA 510(k) record lists X-Cel Specialty Contacts, A Walman Optical Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)?

The FDA product code for Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) 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.

NCT04840563Surface Refractive Index Shift of Kalifilcon A Compared With Dailies Total1 and Precision1 LensesCOMPLETED NCT05285527MiSight 1 Day Safety Post-Approval StudyACTIVE_NOT_RECRUITING NCT06778057Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact LensesCOMPLETED NCT06995781Evaluation of the Safety and Efficacy of PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3)COMPLETED 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

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.