FDA product code KCW: Epilator, High Frequency, Needle-Type
KCW is the FDA product code for epilator, high frequency, needle-type. It is a Class I device, regulated under 21 CFR 878.5350 and reviewed by the General and Plastic Surgery panel. FDA has cleared 43 510(k) submissions under KCW, from 25 different applicants. The average 510(k) review took 78 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Epilator, High Frequency, Needle-Type |
| Device class | Class I |
| Regulation | 21 CFR 878.5350 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KCW clearance
Top KCW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| R. A. Fischer Co. Corp. | 8 | 1996-01-05 |
| Instantron | 7 | 1994-09-16 |
| L.P. Systems Corp. | 2 | 1995-01-12 |
| Skin Deep, Inc. | 2 | 1991-10-15 |
| Ime Co. , Ltd. | 2 | 1988-05-04 |
20 more applicants have KCW clearances. See the full list in Caduvo.
Most recent KCW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K954031 | R. A. Fischer Co. Corp. | COMPU-BLEND EPILATOR | 1996-01-05 | 130 |
| K952611 | Sterex Electrolysis Intl., Ltd. | STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION | 1995-10-18 | 133 |
| K943928 | Dectro Intl., Inc. | APILUS ELECTROPIL | 1995-01-12 | 153 |
| K945192 | L.P. Systems Corp. | HAIR REMOVAL SYSTEM | 1995-01-12 | 80 |
| K943396 | Instantron | THE ELITE SPECTRUM | 1994-09-16 | 64 |
Recalls for KCW devices
openFDA lists no recalls for product code KCW.
Frequently asked questions
What is FDA product code KCW?
KCW is the FDA product code for epilator, high frequency, needle-type. It is a Class I device, regulated under 21 CFR 878.5350 and reviewed by the General and Plastic Surgery panel.
What device class is KCW?
Class I, regulation 21 CFR 878.5350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KCW?
Across 43 cleared submissions the average was 78 days from receipt to decision (median 51).
Which companies have the most KCW clearances?
R. A. Fischer Co. Corp. (8); Instantron (7); L.P. Systems Corp. (2); Skin Deep, Inc. (2); Ime Co. , Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code KCW
- Run a recall and safety report across every KCW manufacturer
- Watch product code KCW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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