The following data is part of a premarket notification filed by Electro-kinetic Eng/mfg with the FDA for Depilator, Derma-i & Derma-ii.
| Device ID | K770791 |
| 510k Number | K770791 |
| Device Name: | DEPILATOR, DERMA-I & DERMA-II |
| Classification | Epilator, High Frequency, Tweezer-type |
| Applicant | ELECTRO-KINETIC ENG/MFG 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KCX |
| CFR Regulation Number | 878.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-05-02 |
| Decision Date | 1981-01-26 |