Cleared Traditional

K200243 - ACUVUE (senofilcon A) Soft Contact Lens...

K200243 is an FDA 510(k) clearance for ACUVUE (senofilcon A) Soft Contact Lens..., manufactured by Johnson & Johnson Vision Care, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K200243 · Johnson & Johnson Vision Care, Inc. · Ophthalmic device
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Mar 2020
Decision
46d
Days
Class 2
Risk

K200243 is an FDA 510(k) clearance for the ACUVUE (senofilcon A) Soft Contact Lens Multifocal. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Johnson & Johnson Vision Care, Inc. (Jacksonville, US). The FDA issued a Cleared decision on March 17, 2020 after a review of 46 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 Johnson & Johnson Vision Care, Inc. devices

FDA 510(k) Submission Details - K200243

510(k) Number K200243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2020
Decision Date March 17, 2020
Days to Decision 46 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
64d faster than avg
Panel avg: 110d · This submission: 46d
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 K200243.
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K192225 · Vizionfocus, Inc. · Dec 2019
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ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens
K192129 · Clearlab SG Pte, Ltd. · Sep 2019