Cleared Traditional

K163401 - Nix Ultra Lice Treatment Kit

K163401 is an FDA 510(k) clearance for Nix Ultra Lice Treatment Kit, manufactured by Medtech Products, Inc.. The device is a Class 1 General Hospital device with product code LJL cleared through the Traditional 510(k) pathway after a 106-day FDA review.

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

FDA 510(k) Submission Details - K163401

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
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

LJL Device Classification - Class 1, General Controls

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.