Cleared Special

K230785 - Precision1

K230785 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 Special 510(k) pathway after a 29-day FDA review.

K230785 · Alcon Laboratories, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
29d
Days
Class 2
Risk

K230785 is an FDA 510(k) clearance for the Precision1, Precision1 for Astigmatism. 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 April 20, 2023 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alcon Laboratories, Inc. devices

Submission Details

510(k) Number K230785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2023
Decision Date April 20, 2023
Days to Decision 29 days
Submission Type Special
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
81d faster than avg
Panel avg: 110d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Consultant

Alcon / Ciba Vision GmbH
Andreas Friese

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K230785.
DAILIES TOTAL1®
K232921 · Alcon Laboratories, Inc. · Nov 2023
IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
K230824 · Art Optical Contact Lens, Inc. · Sep 2023
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
K222885 · Pegavision Corporation · May 2023
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens
K222954 · Innova Vision, Inc. · Mar 2023
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
K220613 · Bausch & Lomb, Incorporated · Mar 2023
POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens
K221517 · INTEROJO, Inc. · Oct 2022