Precision1 +5 more— 510(k) K243909
Substantially EquivalentAlcon 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
- Product 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
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More clearances from Alcon Laboratories, Inc.
view allAdverse 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.