Cleared Traditional

K151562 - Resultz Lice & Egg Removal Kit

K151562 is an FDA 510(k) clearance for Resultz Lice & Egg Removal Kit, manufactured by Piedmont Pharmaceuticals, LLC. The device is a Class 1 General Hospital device with product code LJL cleared through the Traditional 510(k) pathway after a 698-day FDA review.

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.

FDA 510(k) Submission Details - K151562

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
569d slower than avg
Panel avg: 129d · This submission: 698d
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.

Regulatory Consultant

Compliance Architects
Diane Sudduth

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LJL Detectors And Removers, Lice, (including Combs)

All 8
Devices cleared under the same product code (LJL) and FDA review panel - the closest regulatory comparables to K151562.
Nix Ultra Lice Treatment Kit
K163401 · Medtech Products, Inc. · Mar 2017
LOUSEBUSTER
K093144 · Larada Sciences · Dec 2009
LOUSEBUSTER
K083206 · Larada Sciences · Mar 2009
KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT
K991958 · Kiel Laboratories, Inc. · Aug 1999
CLEAR (TM) LICE EGG REMOVER SYSTEM
K981147 · Care Technologies, Inc. · Jun 1998
LICEMEISTER COMB
K981250 · National Pediculosis Assoc. · May 1998
K151562 · Resultz Lice & Egg Removal Kit
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