Precision1 +5 more— 510(k) K243909

Substantially Equivalent

Alcon Laboratories, Inc.

FDA 510(k) clearance K243909 for Precision1 +5 more, Substantially Equivalent on 2025-01-13. Applicant: Alcon Laboratories, Inc.. Device class: 2.

Clearance details

Device name as filed
Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric
Applicant
Alcon Laboratories, Inc.
Product code
Code LPL
Device class
Class 2
Regulation
21 CFR 886.5925
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Fort Worth, TX, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LPL

product code LPL
Injury
988
Other
4
Total
992

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.