← Product Code [KCW](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW) · K943928

# APILUS ELECTROPIL (K943928)

_Dectro Intl., Inc. · KCW · Jan 12, 1995 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K943928

## Device Facts

- **Applicant:** Dectro Intl., Inc.
- **Product Code:** [KCW](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW.md)
- **Decision Date:** Jan 12, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.5350
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K943928](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K943928)

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