The following data is part of a premarket notification filed by Wavelight Laser Technologie Ag with the FDA for Sinon.
| Device ID | K040433 | 
| 510k Number | K040433 | 
| Device Name: | SINON | 
| Classification | Powered Laser Surgical Instrument | 
| Applicant | WAVELIGHT LASER TECHNOLOGIE AG 5 TIMBER LANE North Reading, MA 01864 | 
| Contact | Maureen O'connell | 
| Correspondent | Maureen O'connell WAVELIGHT LASER TECHNOLOGIE AG 5 TIMBER LANE North Reading, MA 01864 | 
| Product Code | GEX | 
| CFR Regulation Number | 878.4810 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2004-02-19 | 
| Decision Date | 2004-05-19 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SINON  79007659  3181080 Dead/Cancelled | Alma Lasers Ltd. 2004-10-05 | 
|  SINON  74363701  1991494 Dead/Cancelled | Liu, Louise Yan 1993-02-26 |