Cleared Traditional

K163401 - Nix Ultra Lice Treatment Kit (FDA 510(k) Clearance)

Class I General Hospital device.

K163401 · Medtech Products, Inc. · General Hospital
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Mar 2017
Decision
106d
Days
Class 1
Risk

K163401 is an FDA 510(k) clearance for the Nix Ultra Lice Treatment Kit. Classified as Detectors And Removers, Lice, (including Combs) (product code LJL), Class I - General Controls.

Submitted by Medtech Products, Inc. (Tarrytown, US). The FDA issued a Cleared decision on March 21, 2017 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5960 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtech Products, Inc. devices

Submission Details

510(k) Number K163401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2016
Decision Date March 21, 2017
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 128d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJL Detectors And Removers, Lice, (including Combs)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5960
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.