HAIR TRONICS MODEL HT8000
Device Facts
| Record ID | K915845 |
|---|---|
| Device Name | HAIR TRONICS MODEL HT8000 |
| Applicant | Global Tronics Intl., Inc. |
| Product Code | KCX · General, Plastic Surgery |
| Decision Date | Jul 29, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5360 |
| Device Class | Class 1 |
Regulatory Classification
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.