Cleared Traditional

K160212 - ACUVUE (senofilcon C) Soft Contact Lens

K160212 is an FDA 510(k) clearance for ACUVUE (senofilcon C) 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 59-day FDA review.

K160212 · Johnson & Johnson Vision Care, Inc. · Ophthalmic device
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Mar 2016
Decision
59d
Days
Class 2
Risk

K160212 is an FDA 510(k) clearance for the ACUVUE (senofilcon C) Soft Contact Lens. 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 28, 2016 after a review of 59 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 - K160212

510(k) Number K160212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2016
Decision Date March 28, 2016
Days to Decision 59 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 110d · This submission: 59d
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 165
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K160212.
AIR OPTIX COLORS
K162596 · Alcon Laboratories, Inc. · Oct 2016
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
K160803 · CooperVision, Inc. · Jul 2016
AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric
K160609 · Alcon Laboratories, Inc. · May 2016
Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist
K151918 · Bausch & Lomb, Incorporated · Feb 2016
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
K153642 · Alcon Laboratories, Inc. · Jan 2016
Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
K153643 · Alcon Laboratories, Inc. · Jan 2016