The following data is part of a premarket notification filed by Instantron with the FDA for The Blendtone Royale.
| Device ID | K943398 |
| 510k Number | K943398 |
| Device Name: | THE BLENDTONE ROYALE |
| Classification | Epilator, High Frequency, Needle-type |
| Applicant | INSTANTRON 3124 PAWTUCKET AVE. East Providence, RI 02915 -5195 |
| Contact | Stephen A Bonzagni |
| Correspondent | Stephen A Bonzagni INSTANTRON 3124 PAWTUCKET AVE. East Providence, RI 02915 -5195 |
| Product Code | KCW |
| CFR Regulation Number | 878.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-14 |
| Decision Date | 1994-09-16 |