Cleared Traditional

K915845 - HAIR TRONICS MODEL HT8000

K915845 is an FDA 510(k) clearance for HAIR TRONICS MODEL HT8000, manufactured by Global Tronics Intl., Inc.. The device is a Class 1 General & Plastic Surgery device with product code KCX cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K915845 · Global Tronics Intl., Inc. · General & Plastic Surgery device
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Jul 1992
Decision
216d
Days
Class 1
Risk

K915845 is an FDA 510(k) clearance for the HAIR TRONICS MODEL HT8000. Classified as Epilator, High Frequency, Tweezer-type (product code KCX), Class I - General Controls.

Submitted by Global Tronics Intl., Inc. (Newbury Park, US). The FDA issued a Cleared decision on July 29, 1992 after a review of 216 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5360 - 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 Global Tronics Intl., Inc. devices

FDA 510(k) Submission Details - K915845

510(k) Number K915845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1991
Decision Date July 29, 1992
Days to Decision 216 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 115d · This submission: 216d
Pathway characteristics
Predicate-based equivalence.

KCX Device Classification - Class 1, General Controls

Product Code KCX Epilator, High Frequency, Tweezer-type
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.5360
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.