Detectors And Removers, Lice, (Including Combs)
Detectors and Removers, Lice (Including Combs) are devices used to detect the presence of lice and physically remove them from the hair and scalp, including mechanical lice combs and similar tools. This device is classified as FDA Class 1, the lowest risk category, subject only to general controls such as proper labeling and manufacturing practices. The product code is LJL, regulated under 21 CFR 880.5960, within the General Hospital medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LJL
- Device Class
- FDA class 1
- Regulation Number
- 880.5960
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K151562 | Resultz Lice & Egg Removal Kit | May 08, 2017 | Substantially Equivalent | Piedmont Pharmaceuticals, LLC |
| K163401 | Nix Ultra Lice Treatment Kit | Mar 21, 2017 | Substantially Equivalent | Medtech Products, Inc. |
| K093144 | LOUSEBUSTER | Dec 16, 2009 | Substantially Equivalent | Larada Sciences |
| K083206 | LOUSEBUSTER | Mar 10, 2009 | Substantially Equivalent | Larada Sciences |
| K991958 | KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT | Aug 13, 1999 | Substantially Equivalent | Kiel Laboratories, Inc. |
| K981147 | CLEAR (TM) LICE EGG REMOVER SYSTEM | Jun 09, 1998 | Substantially Equivalent | Care Technologies, Inc. |
| K981250 | LICEMEISTER COMB | May 28, 1998 | Substantially Equivalent | National Pediculosis Assoc. |
| K981037 | CLEAR (TM) SPECIAL NIT COMB | May 22, 1998 | Substantially Equivalent | Care Technologies, Inc. |
| K930859 | ROBI COMBI | Feb 28, 1994 | Substantially Equivalent | Epilady 2000, LLC |
| K822574 | INNOMED PD-1 KIT | Oct 13, 1982 | Substantially Equivalent | Innomed Corp. |
| K822421 | INNOCOMB LICE COMB | Oct 13, 1982 | Substantially Equivalent | Innovative Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 47 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 48 registration numbers. Click on an entry to view related FDA registrations.