← Product Code [KCW](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW) · K881276

# HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS (K881276)

_Ime Co. , Ltd. · KCW · May 4, 1988 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K881276

## Device Facts

- **Applicant:** Ime Co. , Ltd.
- **Product Code:** [KCW](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW.md)
- **Decision Date:** May 4, 1988
- **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/K881276](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCW/K881276)

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