The following data is part of a premarket notification filed by Osyris with the FDA for Smoothkit+.
| Device ID | K082004 |
| 510k Number | K082004 |
| Device Name: | SMOOTHKIT+ |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OSYRIS 121 RUE CHANZY, BP 90140 Hellemmes , France, FR F59260 |
| Contact | Jaouad Zemmouri |
| Correspondent | Jaouad Zemmouri OSYRIS 121 RUE CHANZY, BP 90140 Hellemmes , France, FR F59260 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-14 |
| Decision Date | 2008-09-26 |
| Summary: | summary |