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510(k) K981147

CLEAR (TM) LICE EGG REMOVER SYSTEM by Care Technologies, Inc. — Product Code LJL

K981147 is an FDA 510(k) premarket notification submitted by Care Technologies, Inc. for the device "CLEAR (TM) LICE EGG REMOVER SYSTEM". The FDA issued a decision of Substantially Equivalent on June 9, 1998. The device falls under product code LJL (Detectors And Removers, Lice, (Including Combs)), a Class I device regulated under 21 CFR 880.5960. Care Technologies, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1998
Date Received
March 30, 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 by Care Technologies, Inc.

  • K981037 — CLEAR (TM) SPECIAL NIT COMB (May 22, 1998)

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)
  • 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