510(k) K083206
- Device
- LOUSEBUSTER
- Applicant
- LARADA SCIENCES
- 510(k) number
- K083206
- Product code
- LJL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-03-10
- Date received
- 2008-10-31
- Regulation
- 880.5960
- Classification name
- Detectors And Removers, Lice, (including Combs)
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PHIL TRIOLO
- Address
- 148 S. 1200 E. Salt Lake City UT US 84102 84102
FDA Registration Numbers#
- 3010166945
- 3006710549
- 9616868
- 3011553249
- 1719513
- 3009488612
- 3013445151
- 3006982887
- 3006537699
- 3004727197
- 3016267994
- 3021499576
- 3011015568
- 1910338
- 3007059822
- 3011512967
- 3008809489
- 2183416
- 3013105881
- 3004416964
- 3015337324
- 3017543622
- 2248574
- 1518939
- 3009155880
- 3014383382
- 3007361893
- 3021059
- 1411456
- 3042156936
- 3017555752
- 9616361
- 3023339107
- 1320681
- 1051594
- 1937639
- 3008501109
- 3009278339
- 3012599695
- 3013579894
- 3016068274
- 3034731361
- 3007092044
- 3011801804
- 2000004234
- 3004649039
- 3017429279
Source Documents#
Other 510(k) Records For Product Code LJL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K151562 | Resultz Lice & Egg Removal Kit | Piedmont Pharmaceuticals, LLC | 2017-05-08 |
| K163401 | Nix Ultra Lice Treatment Kit | Medtech Products, Inc. | 2017-03-21 |
| K093144 | LOUSEBUSTER | Larada Sciences | 2009-12-16 |
| K991958 | KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT | Kiel Laboratories, Inc. | 1999-08-13 |
| K981147 | CLEAR (TM) LICE EGG REMOVER SYSTEM | Care Technologies, Inc. | 1998-06-09 |
| K981250 | LICEMEISTER COMB | National Pediculosis Assoc. | 1998-05-28 |
| K981037 | CLEAR (TM) SPECIAL NIT COMB | Care Technologies, Inc. | 1998-05-22 |
| K930859 | ROBI COMBI | Epilady 2000, LLC | 1994-02-28 |
| K822421 | INNOCOMB LICE COMB | Innovative Products, Inc. | 1982-10-13 |
| K822574 | INNOMED PD-1 KIT | Innomed Corp. | 1982-10-13 |
Legacy Summary#
summary
FDA Review#
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