← Product Code [KCX](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX) · K943872

# COMMANDER MARK II HAIR REMOVAL SYSTEM (K943872)

_The Helene Edgar Corp. · KCX · Oct 26, 1995 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K943872

## Device Facts

- **Applicant:** The Helene Edgar Corp.
- **Product Code:** [KCX](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX.md)
- **Decision Date:** Oct 26, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.5360
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K943872](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K943872)

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