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 | K151161 |
510k Number | K151161 |
Device Name: | VICTUS Femtosecond Laser Platform |
Classification | Ophthalmic Femtosecond Laser |
Applicant | TECHNOLAS PERFECT VISION GMBH MESSERSCHMITTSTR. 1+3 Munich, DE 80992 |
Contact | Friedrich Moritz |
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 | 2015-05-01 |
Decision Date | 2015-06-24 |
Summary: | summary |