Cleared Traditional

HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS (K881276) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K881276 · Ime Co. , Ltd. · General & Plastic Surgery device
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May 1988
Decision
40d
Days
Class 1
Risk

K881276 is an FDA 510(k) clearance for the HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS. Classified as Epilator, High Frequency, Needle-type (product code KCW), Class I - General Controls.

Submitted by Ime Co. , Ltd. (Washington, US). The FDA issued a Cleared decision on May 4, 1988 after a review of 40 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ime Co. , Ltd. devices

Submission Details

510(k) Number K881276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1988
Decision Date May 04, 1988
Days to Decision 40 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
75d faster than avg
Panel avg: 115d · This submission: 40d
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.