HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS
Device Facts
| Record ID | K881276 |
|---|---|
| Device Name | HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS |
| Applicant | Ime Co. , Ltd. |
| Product Code | KCW · General, Plastic Surgery |
| Decision Date | May 4, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5350 |
| Device Class | Class 1 |
Regulatory Classification
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.
