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510(k) K083206

LOUSEBUSTER by Larada Sciences — Product Code LJL

K083206 is an FDA 510(k) premarket notification submitted by Larada Sciences for the device "LOUSEBUSTER". The FDA issued a decision of Substantially Equivalent on March 10, 2009. The device falls under product code LJL (Detectors And Removers, Lice, (Including Combs)), a Class I device regulated under 21 CFR 880.5960. Larada Sciences has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2009
Date Received
October 31, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detectors And Removers, Lice, (Including Combs)
Device Class
Class I
Regulation Number
880.5960
Review Panel
HO
Submission Type

Other clearances by Larada Sciences

  • K093144 — LOUSEBUSTER (December 16, 2009)

Other clearances for product code LJL

  • K151562 — Resultz Lice & Egg Removal Kit (May 8, 2017)
  • K163401 — Nix Ultra Lice Treatment Kit (March 21, 2017)
  • K093144 — LOUSEBUSTER (December 16, 2009)
  • K991958 — KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT (August 13, 1999)
  • K981147 — CLEAR (TM) LICE EGG REMOVER SYSTEM (June 9, 1998)
  • K981250 — LICEMEISTER COMB (May 28, 1998)
  • K981037 — CLEAR (TM) SPECIAL NIT COMB (May 22, 1998)
  • K930859 — ROBI COMBI (February 28, 1994)
  • K822574 — INNOMED PD-1 KIT (October 13, 1982)
  • K822421 — INNOCOMB LICE COMB (October 13, 1982)

FDA data resources