Cleared Traditional

K161819 - NNR06 Multi-Purpose Solution (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161819 · Bausch & Lomb, Incorporated · Ophthalmic device
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Nov 2016
Decision
147d
Days
Class 2
Risk

K161819 is an FDA 510(k) clearance for the NNR06 Multi-Purpose Solution. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Bausch & Lomb, Incorporated (Rochester, US). The FDA issued a Cleared decision on November 25, 2016 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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 K161819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2016
Decision Date November 25, 2016
Days to Decision 147 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
37d slower than avg
Panel avg: 110d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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 - LPN Accessories, Soft Lens Products

All 119
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