510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161654Substantially Equivalent

NuFACE Gel Primer

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

K161654 is the FDA 510(k) clearance record for NuFACE Gel Primer, a class II device, cleared for Carol Cole Company on under FDA product code GYB (Media, Electroconductive). FDA records list 6 510(k) clearances for Carol Cole Company, from to . As of , FDA records show no recalls naming K161654.

Clearance record

Decision date
Received
(198 days to decision)
Product code
GYB Media, Electroconductive
Regulation
21 CFR 882.1275
Device class
Class II
Review panel
Neurology
Applicant
Carol Cole Company 1325 Sycamore Ave., Vista CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GYB

Trailing 12 months

FDA records hold no clearances under product code GYB in the trailing twelve months.

FDA records show no clearances under product code GYB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GYB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260