Cleared Traditional

K210975 - Bausch + Lomb (kalifilcon A) Soft (hydr...

K210975 is the FDA 510(k) clearance for Bausch + Lomb (kalifilcon A) Soft (hydr... by Bausch & Lomb, Incorporated. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K210975 · Bausch & Lomb, Incorporated · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
53d
Days
Class 2
Risk

K210975 is an FDA 510(k) clearance for the Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia. 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 May 24, 2021 after a review of 53 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 Bausch & Lomb, Incorporated devices

Submission Details

510(k) Number K210975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2021
Decision Date May 24, 2021
Days to Decision 53 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
57d faster than avg
Panel avg: 110d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 160
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K210975.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
K211448 · Pegavision Corporation · Dec 2021
ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)
K210930 · Johnson & Johnson Vision Care, Inc. · Nov 2021
Avaira Vitality
K213164 · CooperVision, Inc. · Oct 2021
AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens
K210609 · Vp Optics · Apr 2021
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere
K210436 · Alcon Laboratories, Inc. · Apr 2021
Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo
K202129 · Largan Medical Co., Ltd. · Apr 2021