The following data is part of a premarket notification filed by Universal H.r. System, Inc. with the FDA for Epi 2.
| Device ID | K935706 |
| 510k Number | K935706 |
| Device Name: | EPI 2 |
| Classification | Epilator, High Frequency, Tweezer-type |
| Applicant | UNIVERSAL H.R. SYSTEM, INC. 4601 W. KENNEDY BLVD., SUITE 107 Tampa, FL 33609 |
| Contact | William H Simpson |
| Correspondent | William H Simpson UNIVERSAL H.R. SYSTEM, INC. 4601 W. KENNEDY BLVD., SUITE 107 Tampa, FL 33609 |
| Product Code | KCX |
| CFR Regulation Number | 878.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-30 |
| Decision Date | 1997-02-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EPI 2 75474217 not registered Dead/Abandoned |
Universal Hair Removal System, Inc. 1998-04-24 |