FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LOUSEBUSTER
K Number: K083206
·
Decision Mar 10, 2009
Classifications
1
FEI Numbers
47
Registration Numbers
48
Same Product Code
10
Applicant Total
2
Review Days
130
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LOUSEBUSTER
- K Number
- K083206
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5960
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Larada Sciences
- Date Received
- October 31, 2008
- Decision Date
- March 10, 2009
- Product Code
- LJL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LJL | Detectors And Removers, Lice, (Including Combs) | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJL), ordered by most recent decision date.
Resultz Lice & Egg Removal Kit
FDA 510(k)
FDA Class 1
·General Hospital
Nix Ultra Lice Treatment Kit
FDA 510(k)
FDA Class 1
·General Hospital
LOUSEBUSTER
FDA 510(k)
FDA Class 1
·General Hospital
KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT
FDA 510(k)
FDA Class 1
·General Hospital
CLEAR (TM) LICE EGG REMOVER SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
LICEMEISTER COMB
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Larada Sciences
| K Number | Device Name | ||
|---|---|---|---|
| K093144 | LOUSEBUSTER | Dec 16, 2009 | Substantially Equivalent |