Cleared Traditional

STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION (K952611) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K952611 · Sterex Electrolysis Intl., Ltd. · General & Plastic Surgery device
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Oct 1995
Decision
133d
Days
Class 1
Risk

K952611 is an FDA 510(k) clearance for the STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION. Classified as Epilator, High Frequency, Needle-type (product code KCW), Class I - General Controls.

Submitted by Sterex Electrolysis Intl., Ltd. (Birmingham, GB). The FDA issued a Cleared decision on October 18, 1995 after a review of 133 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 Sterex Electrolysis Intl., Ltd. devices

Submission Details

510(k) Number K952611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1995
Decision Date October 18, 1995
Days to Decision 133 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 115d · This submission: 133d
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.