Cleared Traditional

AHRS EPILATOR 629 (K892514) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K892514 · American Hair Removal System Co. · General & Plastic Surgery device
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Aug 1990
Decision
490d
Days
Class 1
Risk

K892514 is an FDA 510(k) clearance for the AHRS EPILATOR 629. Classified as Epilator, High Frequency, Tweezer-type (product code KCX), Class I - General Controls.

Submitted by American Hair Removal System Co. (Southern Pines, US). The FDA issued a Cleared decision on August 14, 1990 after a review of 490 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all American Hair Removal System Co. devices

Submission Details

510(k) Number K892514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date August 14, 1990
Days to Decision 490 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
375d slower than avg
Panel avg: 115d · This submission: 490d
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.