Home / 510(k) Clearances / K981250

510(k) K981250

LICEMEISTER COMB by National Pediculosis Assoc. — Product Code LJL

K981250 is an FDA 510(k) premarket notification submitted by National Pediculosis Assoc. for the device "LICEMEISTER COMB". The FDA issued a decision of Substantially Equivalent on May 28, 1998. 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 28, 1998
Date Received
April 6, 1998
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

  • K151562 — Resultz Lice & Egg Removal Kit (May 8, 2017)
  • 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)
  • 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