Cleared Traditional

K151562 - Resultz Lice & Egg Removal Kit (FDA 510(k) Clearance)

Class I General Hospital device.

K151562 · Piedmont Pharmaceuticals, LLC · General Hospital
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May 2017
Decision
698d
Days
Class 1
Risk

K151562 is an FDA 510(k) clearance for the Resultz Lice & Egg Removal Kit. Classified as Detectors And Removers, Lice, (including Combs) (product code LJL), Class I - General Controls.

Submitted by Piedmont Pharmaceuticals, LLC (Greensboro, US). The FDA issued a Cleared decision on May 8, 2017 after a review of 698 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Piedmont Pharmaceuticals, LLC devices

Submission Details

510(k) Number K151562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2015
Decision Date May 08, 2017
Days to Decision 698 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
570d slower than avg
Panel avg: 128d · This submission: 698d
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.