Cleared Traditional

HAIR TRONICS MODEL HT8000 (K915845) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

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

Submission Details

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.

Device Classification

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.