The following data is part of a premarket notification filed by Wavelight Laser Technologie Ag with the FDA for Wavelight Idas.
| Device ID | K053604 |
| 510k Number | K053604 |
| Device Name: | WAVELIGHT IDAS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | WAVELIGHT LASER TECHNOLOGIE AG FRANKFURTER STRASSE 229 Neu-isenburg, Hessen, DE 63263 |
| Contact | Thorsten Creter |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-12-27 |
| Decision Date | 2006-02-22 |
| Summary: | summary |