LOUSEBUSTER
FDA 510(k) clearance K093144 · decided 2009-12-16
Clearance details
- K-number
- K093144
- Device name
- LOUSEBUSTER
- Applicant
- Larada Sciences
- Decision
- Substantially Equivalent
- Date received
- 2009-10-05
- Decision date
- 2009-12-16
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- LJL
- Device class
- 1
- Regulation number
- 880.5960
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 (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 |
Recalls involving this device
No recalls on record reference this clearance.