LJL · Detectors And Removers, Lice, (Including Combs)
General Hospital · 21 CFR 880.5960 · Class 1
Overview
| Product Code | LJL |
|---|---|
| Device Name | Detectors And Removers, Lice, (Including Combs) |
| Regulation | 21 CFR 880.5960 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
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 | Resultz Lice & Egg Removal Kit | Piedmont Pharmaceuticals, LLC | May 8, 2017 | SESE |
| K163401 | Nix Ultra Lice Treatment Kit | Medtech Products, Inc. | Mar 21, 2017 | SESE |
| K093144 | LOUSEBUSTER | Larada Sciences | Dec 16, 2009 | SESE |
| K083206 | LOUSEBUSTER | Larada Sciences | Mar 10, 2009 | SESE |
| K991958 | KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT | Kiel Laboratories, Inc. | Aug 13, 1999 | SESE |
| K981147 | CLEAR (TM) LICE EGG REMOVER SYSTEM | Care Technologies, Inc. | Jun 9, 1998 | SESE |
| K981250 | LICEMEISTER COMB | National Pediculosis Assoc. | May 28, 1998 | SESE |
| K981037 | CLEAR (TM) SPECIAL NIT COMB | Care Technologies, Inc. | May 22, 1998 | SESE |
| K930859 | ROBI COMBI | Epilady 2000, LLC | Feb 28, 1994 | SESE |
| K822574 | INNOMED PD-1 KIT | Innomed Corp. | Oct 13, 1982 | SESE |
| K822421 | 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
