Submission Details
| 510(k) Number | K182902 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 16, 2018 |
| Decision Date | December 11, 2018 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
Precision1
Dec 2018
Decision
56d
Days
Class 2
Risk
About This 510(k) Submission
K182902 is an FDA 510(k) clearance for the Precision1, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on December 11, 2018, 56 days after receiving the submission on October 16, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.
Device Classification
| Product Code | LPL — Lenses, Soft Contact, Daily Wear |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5925 |
Manufacturer
Similar Devices — LPL Lenses, Soft Contact, Daily Wear
All 480
K252385 · Pegavision Corporation
· Mar 2026
K254052 · Alcon Laboratories, Inc.
· Feb 2026
K251683 · Bruno Vision Care, LLC
· Dec 2025
K250364 · St. shine Optical Co., Ltd.
· Oct 2025
K244009 · Yung Sheng Optical Co., Ltd.
· Sep 2025
K251095 · Pegavision Corporation
· Sep 2025
More from Alcon Laboratories, Inc.
View all
K254052
· LPL · Feb 2026
K252682
· OOE · Sep 2025
K243896
· OOE · Apr 2025
K243909
· LPL · Jan 2025
K242184
· MPA · Dec 2024