Cleared Traditional

GUIBOR MICROELECTROLYSIS UNIT 18 (K851318) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K851318 · Galvanic Medical Instruments, Inc. · General & Plastic Surgery device
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Aug 1985
Decision
140d
Days
Class 1
Risk

K851318 is an FDA 510(k) clearance for the GUIBOR MICROELECTROLYSIS UNIT 18. Classified as Epilator, High Frequency, Needle-type (product code KCW), Class I - General Controls.

Submitted by Galvanic Medical Instruments, Inc. (Paramus, US). The FDA issued a Cleared decision on August 20, 1985 after a review of 140 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5350 - the FDA general and plastic surgery 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Galvanic Medical Instruments, Inc. devices

Submission Details

510(k) Number K851318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1985
Decision Date August 20, 1985
Days to Decision 140 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 115d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCW Epilator, High Frequency, Needle-type
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.5350
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.