The following data is part of a premarket notification filed by Wavelight Laser Technologie Ag with the FDA for Wavelight Sinon.
| Device ID | K050218 |
| 510k Number | K050218 |
| Device Name: | WAVELIGHT SINON |
| Classification | Powered Laser Surgical Instrument |
| Applicant | WAVELIGHT LASER TECHNOLOGIE AG FRANKFURTER STRASSE 229 Neu-isenburg, DE D-63263 |
| Contact | Manfred Drax |
| Correspondent | Morten S Christensen UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-01-31 |
| Decision Date | 2005-02-15 |
| Summary: | summary |