510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K201680Substantially Equivalent

NuFACE Mini Plus

Carole Cole Company, Vista CA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201680 is the FDA 510(k) clearance record for NuFACE Mini Plus, a class II device, cleared for Carole Cole Company on under FDA product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes). FDA records list one 510(k) clearance for Carole Cole Company. As of , FDA records show no recalls naming K201680.

Clearance record

Decision date
Received
(242 days to decision)
Product code
NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Carole Cole Company 1325 Sycamore Ave., Vista CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFO

Trailing 12 months
9 clearances under product code NFO in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code NFO, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20260
April 20260
May 20262
June 20261
July 20261
August 20261
September 20262
October 20260