Cleared Traditional

BRUSHING (K861803) - FDA 510(k) Clearance

K861803 · Beaute Naturelle International, Inc. · General & Plastic Surgery device
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Jun 1986
Decision
24d
Days
-
Risk

K861803 is an FDA 510(k) clearance for the BRUSHING.

Submitted by Beaute Naturelle International, Inc. (Mcallen, US). The FDA issued a Cleared decision on June 2, 1986 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Beaute Naturelle International, Inc. devices

Submission Details

510(k) Number K861803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1986
Decision Date June 02, 1986
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -