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
K952611Substantially Equivalent

Sterex Sterile Disposale Electrolysis Needle for Use in Epilation

Sterex Electrolysis Intl., Ltd., Birmingham, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952611 is the FDA 510(k) clearance record for STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION, a class I device, cleared for Sterex Electrolysis Intl., Ltd. on under FDA product code KCW (Epilator, High Frequency, Needle-Type). FDA records list one 510(k) clearance for Sterex Electrolysis Intl., Ltd. As of , FDA records show no recalls naming K952611.

Clearance record

Decision date
Received
(133 days to decision)
Product code
KCW Epilator, High Frequency, Needle-Type
Regulation
21 CFR 878.5350
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Sterex Electrolysis Intl., Ltd. 174 Kings Rd., Birmingham, GB
510(k) summary
Summary
Third party review
No

Clearances, product code KCW

Trailing 12 months

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

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