The following data is part of a premarket notification filed by Sterex Electrolysis Intl., Ltd. with the FDA for Sterex Sterile Disposale Electrolysis Needle For Use In Epilation.
| Device ID | K952611 |
| 510k Number | K952611 |
| Device Name: | STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION |
| Classification | Epilator, High Frequency, Needle-type |
| Applicant | STEREX ELECTROLYSIS INTL., LTD. 174 KINGS ROAD TYSELEY Birmingham, GB B11 2ap |
| Product Code | KCW |
| CFR Regulation Number | 878.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-07 |
| Decision Date | 1995-10-18 |