The following data is part of a premarket notification filed by Nemectron Medical, Inc. with the FDA for Softepil.
| Device ID | K843735 |
| 510k Number | K843735 |
| Device Name: | SOFTEPIL |
| Classification | Epilator, High Frequency, Tweezer-type |
| Applicant | NEMECTRON MEDICAL, INC. 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 | 1984-09-24 |
| Decision Date | 1984-10-25 |