The following data is part of a premarket notification filed by Technolas Perfect Vision Gmbh with the FDA for Victus Femtosecond Laser Platform.
| Device ID | K122386 |
| 510k Number | K122386 |
| Device Name: | VICTUS FEMTOSECOND LASER PLATFORM |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | TECHNOLAS PERFECT VISION GMBH PO BOX 17190 Anaheim, CA 92817 -7190 |
| Contact | Betty M Johnson |
| Correspondent | Betty M Johnson TECHNOLAS PERFECT VISION GMBH PO BOX 17190 Anaheim, CA 92817 -7190 |
| Product Code | OOE |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-06 |
| Decision Date | 2013-02-08 |
| Summary: | summary |