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510(k) K151562

Resultz Lice & Egg Removal Kit by Piedmont Pharmaceuticals, LLC — Product Code LJL

K151562 is an FDA 510(k) premarket notification submitted by Piedmont Pharmaceuticals, LLC for the device "Resultz Lice & Egg Removal Kit". The FDA issued a decision of Substantially Equivalent on May 8, 2017. The device falls under product code LJL (Detectors And Removers, Lice, (Including Combs)), a Class I device regulated under 21 CFR 880.5960.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2017
Date Received
June 10, 2015
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 for product code LJL

  • K163401 — Nix Ultra Lice Treatment Kit (March 21, 2017)
  • K093144 — LOUSEBUSTER (December 16, 2009)
  • K083206 — LOUSEBUSTER (March 10, 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