Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart F — Therapeutic Devices](/submissions/SU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 878.5360](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/878.5360) → KCX — Epilator, High Frequency, Tweezer-Type # KCX · Epilator, High Frequency, Tweezer-Type _General, Plastic Surgery · 21 CFR 878.5360 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX ## Overview - **Product Code:** KCX - **Device Name:** Epilator, High Frequency, Tweezer-Type - **Regulation:** [21 CFR 878.5360](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/878.5360) - **Device Class:** 1 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## Identification The tweezer-type epilator is an electrical device intended to remove hair. The energy provided at the tip of the tweezer used to remove hair may be radio frequency, galvanic (direct current), or a combination of radio frequency and galvanic energy. ## Classification Rationale Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. ## Recent Cleared Devices (20 of 25) Showing 20 most recent of 25 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K973773](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K973773.md) | DAPELLE HAIR REMOVER | Wellquest Intl., Inc. | Dec 17, 1997 | SESE | | [K973340](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K973340.md) | TWEEZER-TYPE EPILATOR | Mobit, Inc. | Dec 3, 1997 | SESE | | [K973179](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K973179.md) | FEMINIQUE SONIC HAIR REMOVER | Global TV Concepts, Ltd. | Oct 30, 1997 | SESE | | [K973174](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K973174.md) | SONIQUE HAIR REMOVER | Global TV Concepts, Ltd. | Oct 30, 1997 | SESE | | [K972695](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K972695.md) | FINALLY FREE | Mehl/Group Marketing | Oct 22, 1997 | SESE | | [K970338](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K970338.md) | TWEEZER-TYPE EPILATOR | Igia Direct, Inc. | Jul 1, 1997 | SESE | | [K935706](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K935706.md) | EPI 2 | Universal H.R. System, Inc. | Feb 11, 1997 | SESE | | [K943872](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K943872.md) | COMMANDER MARK II HAIR REMOVAL SYSTEM | The Helene Edgar Corp. | Oct 26, 1995 | SESE | | [K952117](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K952117.md) | EPILATOR | Burke Neutech, Inc. | Oct 19, 1995 | SESE | | [K915845](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K915845.md) | HAIR TRONICS MODEL HT8000 | Global Tronics Intl., Inc. | Jul 29, 1992 | SESE | | [K905125](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K905125.md) | GUARANTY HAIR REMOVAL SYSTEM | Stephens Mfg. Co. | Aug 5, 1991 | SESE | | [K892514](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K892514.md) | AHRS EPILATOR 629 | American Hair Removal System Co. | Aug 14, 1990 | SESE | | [K851413](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K851413.md) | EPILATOR 8500 | Lois Yee Cosmetics, Inc. | Jun 10, 1985 | SESE | | [K843735](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K843735.md) | SOFTEPIL | Nemectron Medical, Inc. | Oct 25, 1984 | SESE | | [K843734](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K843734.md) | NEMDI | Nemectron Medical, Inc. | Oct 25, 1984 | SESE | | [K770791](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K770791.md) | DEPILATOR, DERMA-I & DERMA-II | Electro-Kinetic Eng/Mfg | Jan 26, 1981 | SESE | | [K802513](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K802513.md) | DPA 207 PERSONAL | Hill, Farrer & Borrill | Dec 16, 1980 | SESE | | [K782119](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K782119.md) | DEBUTRON | Martin Electric Co. | Feb 26, 1979 | SESE | | [K780348](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K780348.md) | EPILATION TYPE DEVICE | Mehl, Thomas L. | May 18, 1978 | SESE | | [K772322](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K772322.md) | DEPILATORY, ELECTRONIC | Dura Corp., The | Jan 3, 1978 | SESE | ## Top Applicants - Electronic Depilatory, Inc. — 3 clearances - Global TV Concepts, Ltd. — 2 clearances - Nemectron Medical, Inc. — 2 clearances - American Hair Removal System Co. — 1 clearance - Burke Neutech, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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