Cleared Traditional

K802513 - DPA 207 PERSONAL

K802513 is an FDA 510(k) clearance for DPA 207 PERSONAL, manufactured by Hill, Farrer & Borrill. The device is a Class 1 General & Plastic Surgery device with product code KCX cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K802513 · Hill, Farrer & Borrill · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1980
Decision
62d
Days
Class 1
Risk

K802513 is an FDA 510(k) clearance for the DPA 207 PERSONAL. Classified as Epilator, High Frequency, Tweezer-type (product code KCX), Class I - General Controls.

Submitted by Hill, Farrer & Borrill (Los Angeles, US). The FDA issued a Cleared decision on December 16, 1980 after a review of 62 days - a notably fast clearance 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: 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 Hill, Farrer & Borrill devices

FDA 510(k) Submission Details - K802513

510(k) Number K802513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1980
Decision Date December 16, 1980
Days to Decision 62 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
53d faster than avg
Panel avg: 115d · This submission: 62d
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.