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

Epilator, High Frequency, Tweezer-Type

21 CFR 878.5360 / General, Plastic Surgery
FDA source (opens on fda.gov)

KCX is the FDA product code for Epilator, High Frequency, Tweezer-Type, a class I device type, regulated under 21 CFR 878.5360. As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KCX
Device name
Epilator, High Frequency, Tweezer-Type
Regulation
21 CFR 878.5360
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
25
Ingested recalls
0

Clearances, product code KCX

By decision year
25 clearances under product code KCX with a decision year between 1976 and 1997, 1997 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code KCX by decision year
YearClearances
19761
19774
19782
19791
19801
19811
19842
19851
19901
19911
19921
19952
19977

Applicants with the most clearances

Product code KCX
Applicants holding the most 510(k) clearances under product code KCX
ApplicantClearances
Electronic Depilatory, Inc.3
Global TV Concepts, Ltd.2
Nemectron Medical, Inc.2
American Hair Removal System Co.1
Burke Neutech, Inc.1
Dura Corp., the1
Electro-Kinetic Eng/Mfg1
Epco Hair Removal Corp.1
Epilator Corp.1
Global Tronics Intl., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order