510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K952117Substantially Equivalent

Epilator

Burke Neutech, Inc., St. Petersburg FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952117 is the FDA 510(k) clearance record for EPILATOR, a class I device, cleared for Burke Neutech, Inc. on under FDA product code KCX (Epilator, High Frequency, Tweezer-Type). FDA records list 7 510(k) clearances for Burke Neutech, Inc., from to . As of , FDA records show no recalls naming K952117.

Clearance record

Decision date
Received
(167 days to decision)
Product code
KCX Epilator, High Frequency, Tweezer-Type
Regulation
21 CFR 878.5360
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Burke Neutech, Inc. 1765 Commerce Ave. N, St. Petersburg FL
510(k) summary
Statement
Third party review
No

Clearances, product code KCX

Trailing 12 months

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

FDA records show no clearances under product code KCX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KCX, 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