Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5960](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5960) → LJL — Detectors And Removers, Lice, (Including Combs)

# LJL · Detectors And Removers, Lice, (Including Combs)

_General Hospital · 21 CFR 880.5960 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJL

## Overview

- **Product Code:** LJL
- **Device Name:** Detectors And Removers, Lice, (Including Combs)
- **Regulation:** [21 CFR 880.5960](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5960)
- **Device Class:** 1
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

The lice removal kit is a comb or comb-like device intended to remove and/or kill lice and nits from head and body hair. It may or may not be battery operated.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K151562](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJL/K151562.md) | Resultz Lice & Egg Removal Kit | Piedmont Pharmaceuticals, LLC | May 8, 2017 | SESE |
| [K163401](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJL/K163401.md) | Nix Ultra Lice Treatment Kit | Medtech Products, Inc. | Mar 21, 2017 | SESE |
| [K093144](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJL/K093144.md) | LOUSEBUSTER | Larada Sciences | Dec 16, 2009 | SESE |
| [K083206](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJL/K083206.md) | LOUSEBUSTER | Larada Sciences | Mar 10, 2009 | SESE |
| [K991958](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJL/K991958.md) | KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT | Kiel Laboratories, Inc. | Aug 13, 1999 | SESE |
| [K981147](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJL/K981147.md) | CLEAR (TM) LICE EGG REMOVER SYSTEM | Care Technologies, Inc. | Jun 9, 1998 | SESE |
| [K981250](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJL/K981250.md) | LICEMEISTER COMB | National Pediculosis Assoc. | May 28, 1998 | SESE |
| [K981037](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJL/K981037.md) | CLEAR (TM) SPECIAL NIT COMB | Care Technologies, Inc. | May 22, 1998 | SESE |
| [K930859](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJL/K930859.md) | ROBI COMBI | Epilady 2000, LLC | Feb 28, 1994 | SESE |
| [K822574](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJL/K822574.md) | INNOMED PD-1 KIT | Innomed Corp. | Oct 13, 1982 | SESE |
| [K822421](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJL/K822421.md) | INNOCOMB LICE COMB | Innovative Products, Inc. | Oct 13, 1982 | SESE |

## Top Applicants

- Care Technologies, Inc. — 2 clearances
- Larada Sciences — 2 clearances
- Epilady 2000, LLC — 1 clearance
- Innomed Corp. — 1 clearance
- Innovative Products, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJL](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJL)

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