FDA 510(k)

Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens

K-Number: K182249 · 2018-11-30

Decision Date2018-11-30

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Incorporated. It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K182249. 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 Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens?

Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Bausch & Lomb, Incorporated. The 510(k) number is K182249.

When did Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens receive FDA 510(k) clearance?

Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens received FDA 510(k) clearance on 2018-11-30, under 510(k) number K182249.

Who is the listed applicant for Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens?

The FDA 510(k) record lists Bausch & Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens?

The FDA product code for Ultra (samfilcon A) Multifocal for Astigmatism 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.

NCT053259311-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for PresbyopiaCOMPLETED NCT04840563Surface Refractive Index Shift of Kalifilcon A Compared With Dailies Total1 and Precision1 LensesCOMPLETED NCT05129488Biotrue ONEday Contact Lenses With EPG03 Packaging Solution Compared to Biotrue ONEday Contact LensesCOMPLETED NCT060537361-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact LensesCOMPLETED NCT07696130Evaluation of Visual Outcomes, Complications, and Neuroadaptation Following Bilateral Implantation of enVista Envy Trifocal Intraocular LensesRECRUITING NCT06333015Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract ExtractionCOMPLETED

Other records listing Bausch & Lomb, Incorporated as applicant

PMA P240005Lens, multifocal intraocular PMA P910056intraocular lens PMA P910071Fluid, intraocular PMA P860022Lens, contact (rigid gas permeable), extended wear PMA P010062Lens, contact, orthokeratology, overnight PMA N16895Lenses, soft contact, extended wear

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Related Devices (Code: LPL)

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.