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 | K141379 |
| 510k Number | K141379 |
| Device Name: | VICTUS FEMTOSECOND LASER PLATFORM |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | TECHNOLAS PERFECT VISION GMBH 1025 SANCHEZ STREET San Francisco, CA 94114 |
| Contact | Ken Nehmer |
| Correspondent | Ken Nehmer TECHNOLAS PERFECT VISION GMBH 1025 SANCHEZ STREET San Francisco, CA 94114 |
| Product Code | OOE |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-27 |
| Decision Date | 2015-01-16 |
| Summary: | summary |