COMMANDER MARK II HAIR REMOVAL SYSTEM
Device Facts
| Record ID | K943872 |
|---|---|
| Device Name | COMMANDER MARK II HAIR REMOVAL SYSTEM |
| Applicant | The Helene Edgar Corp. |
| Product Code | KCX · General, Plastic Surgery |
| Decision Date | Oct 26, 1995 |
| 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.
