FDA product code LJL: Detectors And Removers, Lice, (Including Combs)
LJL is the FDA product code for detectors and removers, lice, (including combs). It is a Class I device, regulated under 21 CFR 880.5960 and reviewed by the General Hospital panel. FDA has cleared 11 510(k) submissions under LJL, from 9 different applicants. The average 510(k) review took 158 days (median 71).
Classification
| Field | Value |
|---|---|
| Device name | Detectors And Removers, Lice, (Including Combs) |
| Device class | Class I |
| Regulation | 21 CFR 880.5960 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
510(k) clearances per year for LJL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 402 |
Compare with all 510(k) review times · Search every LJL clearance
Top LJL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Larada Sciences | 2 | 2009-12-16 |
| Care Technologies, Inc. | 2 | 1998-06-09 |
| Piedmont Pharmaceuticals, LLC | 1 | 2017-05-08 |
| Medtech Products, Inc. | 1 | 2017-03-21 |
| Kiel Laboratories, Inc. | 1 | 1999-08-13 |
4 more applicants have LJL clearances. See the full list in Caduvo.
Most recent LJL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151562 | Piedmont Pharmaceuticals, LLC | Resultz Lice & Egg Removal Kit | 2017-05-08 | 698 |
| K163401 | Medtech Products, Inc. | Nix Ultra Lice Treatment Kit | 2017-03-21 | 106 |
| K093144 | Larada Sciences | LOUSEBUSTER | 2009-12-16 | 72 |
| K083206 | Larada Sciences | LOUSEBUSTER | 2009-03-10 | 130 |
| K991958 | Kiel Laboratories, Inc. | KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT | 1999-08-13 | 64 |
Recalls for LJL devices
openFDA lists no recalls for product code LJL.
Frequently asked questions
What is FDA product code LJL?
LJL is the FDA product code for detectors and removers, lice, (including combs). It is a Class I device, regulated under 21 CFR 880.5960 and reviewed by the General Hospital panel.
What device class is LJL?
Class I, regulation 21 CFR 880.5960. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LJL?
Across 11 cleared submissions the average was 158 days from receipt to decision (median 71).
Which companies have the most LJL clearances?
Larada Sciences (2); Care Technologies, Inc. (2); Piedmont Pharmaceuticals, LLC (1); Medtech Products, Inc. (1); Kiel Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LJL
- Run a recall and safety report across every LJL manufacturer
- Watch product code LJL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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