FDA product code KCX: Epilator, High Frequency, Tweezer-Type
KCX is the FDA product code for epilator, high frequency, tweezer-type. It is a Class I device, regulated under 21 CFR 878.5360 and reviewed by the General and Plastic Surgery panel. FDA has cleared 25 510(k) submissions under KCX, from 21 different applicants. The average 510(k) review took 206 days (median 66).
Classification
| Field | Value |
|---|---|
| Device name | Epilator, High Frequency, Tweezer-Type |
| Device class | Class I |
| Regulation | 21 CFR 878.5360 |
| 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 KCX clearance
Top KCX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Electronic Depilatory, Inc. | 3 | 1977-09-06 |
| Global TV Concepts, Ltd. | 2 | 1997-10-30 |
| Nemectron Medical, Inc. | 2 | 1984-10-25 |
| Wellquest Intl., Inc. | 1 | 1997-12-17 |
| Mobit, Inc. | 1 | 1997-12-03 |
16 more applicants have KCX clearances. See the full list in Caduvo.
Most recent KCX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973773 | Wellquest Intl., Inc. | DAPELLE HAIR REMOVER | 1997-12-17 | 76 |
| K973340 | Mobit, Inc. | TWEEZER-TYPE EPILATOR | 1997-12-03 | 89 |
| K973179 | Global TV Concepts, Ltd. | FEMINIQUE SONIC HAIR REMOVER | 1997-10-30 | 66 |
| K973174 | Global TV Concepts, Ltd. | SONIQUE HAIR REMOVER | 1997-10-30 | 66 |
| K972695 | Mehl/Group Marketing | FINALLY FREE | 1997-10-22 | 96 |
Recalls for KCX devices
openFDA lists no recalls for product code KCX.
Frequently asked questions
What is FDA product code KCX?
KCX is the FDA product code for epilator, high frequency, tweezer-type. It is a Class I device, regulated under 21 CFR 878.5360 and reviewed by the General and Plastic Surgery panel.
What device class is KCX?
Class I, regulation 21 CFR 878.5360. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KCX?
Across 25 cleared submissions the average was 206 days from receipt to decision (median 66).
Which companies have the most KCX clearances?
Electronic Depilatory, Inc. (3); Global TV Concepts, Ltd. (2); Nemectron Medical, Inc. (2); Wellquest Intl., Inc. (1); Mobit, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KCX
- Run a recall and safety report across every KCX manufacturer
- Watch product code KCX 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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