Cleared Traditional

K151918 - Biotrue ONEday with NaturMoist

K151918 is the FDA 510(k) clearance for Biotrue ONEday with NaturMoist by Bausch & Lomb, Incorporated. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K151918 · Bausch & Lomb, Incorporated · Ophthalmic device
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Feb 2016
Decision
213d
Days
Class 2
Risk

K151918 is an FDA 510(k) clearance for the Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist.... 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 February 11, 2016 after a review of 213 days - an extended review 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: 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 K151918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2015
Decision Date February 11, 2016
Days to Decision 213 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
103d slower than avg
Panel avg: 110d · This submission: 213d
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 161
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