The following data is part of a premarket notification filed by Synoptic Products with the FDA for Ballet Sterile Disposable Electrolysis.
| Device ID | K883892 |
| 510k Number | K883892 |
| Device Name: | BALLET STERILE DISPOSABLE ELECTROLYSIS |
| Classification | Epilator, High Frequency, Needle-type |
| Applicant | SYNOPTIC PRODUCTS 316 HARVARD ST. Brookline, MA 02146 |
| Contact | James Paisner |
| Correspondent | James Paisner SYNOPTIC PRODUCTS 316 HARVARD ST. Brookline, MA 02146 |
| Product Code | KCW |
| CFR Regulation Number | 878.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-14 |
| Decision Date | 1988-10-20 |