The following data is part of a premarket notification filed by Wavelight Ag with the FDA for Allegro Oculyzer.
| Device ID | K071183 |
| 510k Number | K071183 |
| Device Name: | ALLEGRO OCULYZER |
| Classification | Device, Analysis, Anterior Segment |
| Applicant | WAVELIGHT AG AM WOLFSMANTEL 5 Erlangen, Bavaria, DE 91058 |
| Contact | Alexander Popp |
| Correspondent | Alexander Popp WAVELIGHT AG AM WOLFSMANTEL 5 Erlangen, Bavaria, DE 91058 |
| Product Code | MXK |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-30 |
| Decision Date | 2007-07-20 |
| Summary: | summary |