Precision1

Lenses, Soft Contact, Daily Wear

Alcon Laboratories, Inc.

The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Precision1.

Pre-market Notification Details

• Device ID: K182902
• 510k Number: K182902
• Device Name: Precision1
• Classification: Lenses, Soft Contact, Daily Wear
• Applicant: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 -2099
• Contact: Alicia Plesnarski
• Correspondent: Alicia Plesnarski; Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 -2099
• Product Code: LPL
• CFR Regulation Number: 886.5925 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-10-16
• Decision Date: 2018-12-11
• Summary: summary