Cleared Traditional

K220613 - Bausch + Lomb (kalifilcon A) Soft (hydr...

K220613 is an FDA 510(k) clearance for Bausch + Lomb (kalifilcon A) Soft (hydr..., manufactured by Bausch & Lomb, Incorporated. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 370-day FDA review.

K220613 · Bausch & Lomb, Incorporated · Ophthalmic device
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Mar 2023
Decision
370d
Days
Class 2
Risk

K220613 is an FDA 510(k) clearance for the Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (.... 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 March 8, 2023 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K220613

510(k) Number K220613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2022
Decision Date March 08, 2023
Days to Decision 370 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
260d slower than avg
Panel avg: 110d · This submission: 370d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPL Device Classification - Class 2, Special Controls

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 164
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K220613.
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
K222885 · Pegavision Corporation · May 2023
Precision1, Precision1 for Astigmatism
K230785 · Alcon Laboratories, Inc. · Apr 2023
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens
K222954 · Innova Vision, Inc. · Mar 2023
POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens
K221517 · INTEROJO, Inc. · Oct 2022
AIR OPTIX COLORS
K222500 · Alcon Laboratories, Inc. · Sep 2022
BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
K220143 · Shenzhen Dashicheng Optical Technology Co., Ltd. · Sep 2022