FDA 510(k)

Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal

K-Number: K233856 · 2023-12-29

Decision Date2023-12-29

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal 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 2023-12-29 under 510(k) number K233856. 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 Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal?

Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal is a medical device that received FDA 510(k) clearance on 2023-12-29. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K233856.

When did Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal receive FDA 510(k) clearance?

Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal received FDA 510(k) clearance on 2023-12-29, under 510(k) number K233856.

Who is the listed applicant for Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal?

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 Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal?

The FDA product code for Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal is LPL.

Other records listing Alcon Laboratories, 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.

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

View all 50 devices →

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.