The following data is part of a premarket notification filed by Leo Unlimited, Inc. with the FDA for Epitron Super.
| Device ID | K834572 |
| 510k Number | K834572 |
| Device Name: | EPITRON SUPER |
| Classification | Epilator, High Frequency, Needle-type |
| Applicant | LEO UNLIMITED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KCW |
| CFR Regulation Number | 878.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-29 |
| Decision Date | 1984-04-23 |