Cleared Traditional

K182902 - Precision1

K182902 is the FDA 510(k) clearance for Precision1 by Alcon Laboratories, Inc.. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K182902 · Alcon Laboratories, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
56d
Days
Class 2
Risk

K182902 is an FDA 510(k) clearance for the Precision1. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on December 11, 2018 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alcon Laboratories, Inc. devices

Submission Details

510(k) Number K182902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 110d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03305770 Completed Interventional Industry-sponsored

DD T2 Daily Disposable Registration Trial

107
Patients (actual)
6
Sites
Treatment
Purpose
Double blind
Masking
Condition studied Myopia; Refractive Errors
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Alcon, a Novartis Division
Sponsor Alcon Research (industry)
Started 2017-10-12 → Primary completion 2018-02-21
Primary outcome
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
View full study on ClinicalTrials.gov

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 160
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K182902.
DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives
K190045 · Alcon Laboratories, Inc. · Feb 2019
DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric
K182782 · Alcon Laboratories, Inc. · Jan 2019
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
K181920 · CooperVision, Inc. · Dec 2018
Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens
K182249 · Bausch & Lomb, Incorporated · Nov 2018
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal
K181454 · Alcon Laboratories, Inc. · Nov 2018
Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia
K182674 · Largan Medical Co., Ltd. · Nov 2018