Cleared Traditional

K952611 - STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION

K952611 is an FDA 510(k) clearance for STEREX STERILE DISPOSALE ELECTROLYSIS N..., manufactured by Sterex Electrolysis Intl., Ltd.. The device is a Class 1 General & Plastic Surgery device with product code KCW cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K952611 · Sterex Electrolysis Intl., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K952611

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.

KCW Device Classification - Class 1, General Controls

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.