Home / 510(k) Clearances / K163401

510(k) K163401

Nix Ultra Lice Treatment Kit by Medtech Products, Inc. — Product Code LJL

K163401 is an FDA 510(k) premarket notification submitted by Medtech Products, Inc. for the device "Nix Ultra Lice Treatment Kit". The FDA issued a decision of Substantially Equivalent on March 21, 2017. The device falls under product code LJL (Detectors And Removers, Lice, (Including Combs)), a Class I device regulated under 21 CFR 880.5960. Medtech Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2017
Date Received
December 5, 2016
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 Medtech Products, Inc.

  • K242803 — Compound W Skin Tag Remover (November 6, 2024)
  • K202974 — DenTek Fresh Protect Dental Guard (December 22, 2020)
  • K180933 — DenTek Ultimate Dental Guard (September 17, 2018)
  • K172373 — Compound W Nitro-Freeze (November 2, 2017)
  • K161294 — Compound W Wart Removal System Dual Power (September 15, 2016)
  • K063401 — BANANA RIBBED (March 26, 2007)
  • K012969 — DOUBLE SPRINGERS NONOXNOL 9 CONDOM (June 12, 2002)
  • K993737 — MIGHTY MAN (DYNAMIC LINKERS) (March 20, 2000)
  • K993735 — DOUBLE SPRINGERS (March 20, 2000)
  • K993733 — LOVE LOCKERS (March 20, 2000)

Other clearances for product code LJL

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