Cleared Traditional

D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE) (K895687) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K895687 · Carol Block, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
321d
Days
Class 1
Risk

K895687 is an FDA 510(k) clearance for the D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE). Classified as Epilator, High Frequency, Needle-type (product code KCW), Class I - General Controls.

Submitted by Carol Block, Ltd. (Mc Henry, US). The FDA issued a Cleared decision on August 9, 1990 after a review of 321 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 878.5350 - 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Carol Block, Ltd. devices

Submission Details

510(k) Number K895687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1989
Decision Date August 09, 1990
Days to Decision 321 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
206d slower than avg
Panel avg: 115d · This submission: 321d
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.