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

Epilator, High Frequency, Needle-Type

21 CFR 878.5350 / General, Plastic Surgery
FDA source (opens on fda.gov)

KCW is the FDA product code for Epilator, High Frequency, Needle-Type, a class I device type, regulated under 21 CFR 878.5350. As of , FDA records hold 43 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KCW
Device name
Epilator, High Frequency, Needle-Type
Regulation
21 CFR 878.5350
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
43
Ingested recalls
0

Clearances, product code KCW

By decision year
43 clearances under product code KCW with a decision year between 1978 and 1996, 1988 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code KCW by decision year
YearClearances
19783
19802
19813
19822
19832
19843
19851
19863
19872
19886
19892
19902
19911
19933
19944
19953
19961

Applicants with the most clearances

Product code KCW
Applicants holding the most 510(k) clearances under product code KCW
ApplicantClearances
R. A. Fischer Co. Corp.8
Instantron7
Ime Co., Ltd.2
L.P. Systems Corp.2
Leo Unlimited, Inc.2
Rcx-Western, Inc.2
Skin Deep, Inc.2
A Place of Health & Beauty1
A.R. Hinkel Co., Inc.1
Alexander Thomas, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order