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 | K171014 |
510k Number | K171014 |
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 351 Buena Vista Ave. E, Unit 501E San Francisco, CA 94117 |
Product Code | OOE |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-04-04 |
Decision Date | 2017-10-19 |
Summary: | summary |