LJL
11 FDA 510(k) clearances · Product code
71 daysmedian time to decision
375 days90th percentile
11clearances measured
FDA profile
- Official device name
- Detectors And Removers, Lice, (Including Combs)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5960
- Medical specialty
- General Hospital
- Adverse events (MAUDE)
- 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Resultz Lice & Egg Removal Kit (K151562) | Piedmont Pharmaceuticals, LLC | 2017-05-08 |
| Nix Ultra Lice Treatment Kit (K163401) | Medtech Products, Inc. | 2017-03-21 |
| LOUSEBUSTER (K093144) | Larada Sciences | 2009-12-16 |
| LOUSEBUSTER (K083206) | Larada Sciences | 2009-03-10 |
| KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT (K991958) | Kiel Laboratories, Inc. | 1999-08-13 |
| CLEAR (TM) LICE EGG REMOVER SYSTEM (K981147) | Care Technologies, Inc. | 1998-06-09 |
| LICEMEISTER COMB (K981250) | National Pediculosis Assoc. | 1998-05-28 |
| CLEAR (TM) SPECIAL NIT COMB (K981037) | Care Technologies, Inc. | 1998-05-22 |
| ROBI COMBI (K930859) | Epilady 2000, LLC | 1994-02-28 |
| INNOCOMB LICE COMB (K822421) | Innovative Products, Inc. | 1982-10-13 |
| INNOMED PD-1 KIT (K822574) | Innomed Corp. | 1982-10-13 |
Track LJL automatically
Every clearance here is in the API, with alerts when new ones post.