Cleared Traditional

K200528 - Bausch + Lomb (Kalifilcon A) Soft Conta...

K200528 is the FDA 510(k) clearance for Bausch + Lomb (Kalifilcon A) Soft Conta... by Bausch & Lomb, Incorporated. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K200528 · Bausch & Lomb, Incorporated · Ophthalmic device
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Jun 2020
Decision
92d
Days
Class 2
Risk

K200528 is an FDA 510(k) clearance for the Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) .... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Bausch & Lomb, Incorporated (Rochester, US). The FDA issued a Cleared decision on June 2, 2020 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Bausch & Lomb, Incorporated devices

Submission Details

510(k) Number K200528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2020
Decision Date June 02, 2020
Days to Decision 92 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
18d faster than avg
Panel avg: 110d · This submission: 92d
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
NCT04158466 Completed Interventional Industry-sponsored

A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact Lens

A Study to Evaluate the Safety and Efficacy of a Kalifilcon A Contact Lens for Daily Disposable Use

252
Patients (actual)
16
Sites
Supportive_care
Purpose
Single blind
Masking
Condition studied Contact Lens Wear
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Daniel Donatello
Sponsor Bausch & Lomb Incorporated (industry)
Started 2019-05-31 → Primary completion 2019-11-12
Primary outcome
Mean logMAR Contact Lens Visual Acuity
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 K200528.
Optixon 1-Day
K201013 · Optixon, Inc. · Sep 2020
Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens
K201080 · Visco Vision, Inc. · Jul 2020
Miru 1day UpSide (midafilcon A)
K193399 · Menicon Co, Ltd. · Jun 2020
MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC
K191763 · CooperVision, Inc. · Mar 2020
ACUVUE (senofilcon A) Soft Contact Lens Multifocal
K200243 · Johnson & Johnson Vision Care, Inc. · Mar 2020
Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses
K192225 · Vizionfocus, Inc. · Dec 2019