Cleared Traditional

K930859 - ROBI COMBI

K930859 is an FDA 510(k) clearance for ROBI COMBI, manufactured by Epilady 2000, LLC. The device is a Class 1 General Hospital device with product code LJL cleared through the Traditional 510(k) pathway after a 375-day FDA review.

K930859 · Epilady 2000, LLC · General Hospital
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Feb 1994
Decision
375d
Days
Class 1
Risk

K930859 is an FDA 510(k) clearance for the ROBI COMBI. Classified as Detectors And Removers, Lice, (including Combs) (product code LJL), Class I - General Controls.

Submitted by Epilady 2000, LLC (Washington D.C., US). The FDA issued a Cleared decision on February 28, 1994 after a review of 375 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Epilady 2000, LLC devices

FDA 510(k) Submission Details - K930859

510(k) Number K930859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1993
Decision Date February 28, 1994
Days to Decision 375 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
246d slower than avg
Panel avg: 129d · This submission: 375d
Pathway characteristics
Predicate-based equivalence.

LJL Device Classification - Class 1, General Controls

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.