Cleared Traditional

K222541 - Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K222541 · Bausch & Lomb, Incorporated · Ophthalmic device
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Dec 2022
Decision
106d
Days
Class 2
Risk

K222541 is an FDA 510(k) clearance for the Bausch + Lomb Preservative Free Lubricating and Rewetting Drops. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Bausch & Lomb, Incorporated (Rochester, US). The FDA issued a Cleared decision on December 6, 2022 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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 K222541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2022
Decision Date December 06, 2022
Days to Decision 106 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
4d faster than avg
Panel avg: 110d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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
NCT04175340 Completed Interventional Industry-sponsored

A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop

369
Patients (actual)
15
Sites
Treatment
Purpose
Triple
Masking
Condition studied Contact Lens Wear
Study design Parallel
Eligibility All sexes · 18 Years+
Sponsor Bausch & Lomb Incorporated (industry)
Started 2019-11-07 → Primary completion 2020-02-17
Primary outcome
Overall Comfort Averaged Over All Follow-up Visits
View full study on ClinicalTrials.gov