THE BLENDTONE ROYALE
Device Facts
| Record ID | K943398 |
|---|---|
| Device Name | THE BLENDTONE ROYALE |
| Applicant | Instantron |
| Product Code | KCW · General, Plastic Surgery |
| Decision Date | Sep 16, 1994 |
| 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.
