Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart F — Therapeutic Devices](/submissions/SU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 878.5350](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/878.5350) → KCW — Epilator, High Frequency, Needle-Type # KCW · Epilator, High Frequency, Needle-Type _General, Plastic Surgery · 21 CFR 878.5350 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW ## Overview - **Product Code:** KCW - **Device Name:** Epilator, High Frequency, Needle-Type - **Regulation:** [21 CFR 878.5350](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/878.5350) - **Device Class:** 1 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## Identification A needle-type epilator is a device intended to destroy the dermal papilla of a hair by applying electric current at the tip of a fine needle that has been inserted close to the hair shaft, under the skin, and into the dermal papilla. The electric current may be high-frequency AC current, high-frequency AC combined with DC current, or DC current only. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9. ## Recent Cleared Devices (20 of 43) Showing 20 most recent of 43 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K954031](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K954031.md) | COMPU-BLEND EPILATOR | R. A. Fischer Co. Corp. | Jan 5, 1996 | SESE | | [K952611](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K952611.md) | STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION | Sterex Electrolysis Intl., Ltd. | Oct 18, 1995 | SESE | | [K945192](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K945192.md) | HAIR REMOVAL SYSTEM | L.P. Systems Corp. | Jan 12, 1995 | SESE | | [K943928](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K943928.md) | APILUS ELECTROPIL | Dectro Intl., Inc. | Jan 12, 1995 | SESE | | [K943399](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K943399.md) | THE SS-99 | Instantron | Sep 16, 1994 | SESE | | [K943398](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K943398.md) | THE BLENDTONE ROYALE | Instantron | Sep 16, 1994 | SESE | | [K943396](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K943396.md) | THE ELITE SPECTRUM | Instantron | Sep 16, 1994 | SESE | | [K941227](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K941227.md) | SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL | Instantron | Aug 18, 1994 | SESE | | [K931064](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K931064.md) | THE BLENDTONE EPILATOR | Instantron | Jul 8, 1993 | SESE | | [K931063](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K931063.md) | THE ELITE EPILATOR | Instantron | Jul 8, 1993 | SESE | | [K931062](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K931062.md) | THE VP500 EPILATOR | Instantron | Jul 8, 1993 | SESE | | [K911983](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K911983.md) | WIZARD STERILIZED ELECTROEPILATION NEEDLE | Skin Deep, Inc. | Oct 15, 1991 | SESE | | [K904015](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K904015.md) | ELECTRO-BLEND EPILATOR, MODEL UC-3 | A.R. Hinkel Co., Inc. | Oct 4, 1990 | SESE | | [K895687](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K895687.md) | D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE) | Carol Block, Ltd. | Aug 9, 1990 | SESE | | [K894771](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K894771.md) | EPILATION NEEDLE | Precision Electrolysis Needles, Inc. | Aug 21, 1989 | SESE | | [K893389](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K893389.md) | MODEL SE-5 EPILATOR | R. A. Fischer Co. Corp. | Jun 5, 1989 | SESE | | [K883892](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K883892.md) | BALLET STERILE DISPOSABLE ELECTROLYSIS | Synoptic Products | Oct 20, 1988 | SESE | | [K884079](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K884079.md) | MODEL CBX EPILATOR | R. A. Fischer Co. Corp. | Oct 4, 1988 | SESE | | [K883429](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K883429.md) | LINDSTROM CORDLESS EPILATOR | A Place of Health & Beauty | Sep 28, 1988 | SESE | | [K881276](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K881276.md) | HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS | Ime Co. , Ltd. | May 4, 1988 | SESE | ## Top Applicants - R. A. Fischer Co. Corp. — 8 clearances - Instantron — 7 clearances - Ime Co. , Ltd. — 2 clearances - L.P. Systems Corp. — 2 clearances - Leo Unlimited, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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