Cleared Traditional

KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT (K991958) - FDA 510(k) Clearance

Class I General Hospital device.

K991958 · Kiel Laboratories, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
64d
Days
Class 1
Risk

K991958 is an FDA 510(k) clearance for the KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT. Classified as Detectors And Removers, Lice, (including Combs) (product code LJL), Class I - General Controls.

Submitted by Kiel Laboratories, Inc. (Gainesville, US). The FDA issued a Cleared decision on August 13, 1999 after a review of 64 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5960 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kiel Laboratories, Inc. devices

Submission Details

510(k) Number K991958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1999
Decision Date August 13, 1999
Days to Decision 64 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 129d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJL Detectors And Removers, Lice, (including Combs)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5960
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.