FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions— 510(k) K181796

Substantially Equivalent

Alcon Laboratories, Inc.

FDA 510(k) clearance K181796 for FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions, Substantially Equivalent on 2018-08-03. Applicant: Alcon Laboratories, Inc.. Device class: 2.

Clearance details

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.