K140615 is an FDA 510(k) clearance for the VICTUS FEMTOSECOND LASER PLATFORM. Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.
Submitted by Technolas Perfect Vision GmbH (Anaheim Hills, US). The FDA issued a Cleared decision on July 15, 2014 after a review of 127 days - within the typical 510(k) review window.
This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.
View all Technolas Perfect Vision GmbH devices
NCT01971177
Completed
Interventional
Industry-sponsored
Addressing of Efficacy and Safety of Femtosecond-laser Assisted Versus Manual Lens Fragmentation Procedure
A Multi-centre, Multi-surgeon, Randomized, Controlled, Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Impact of Cataract Grade on the Efficacy and Safety of Femtosecond-laser Assisted Lens Fragmentation Procedure
| Condition studied |
Cataract |
| Study design |
Parallel |
| Eligibility |
All sexes
· 40 Years+
|
| Principal investigator |
Pavel Stodulka, Dr. med |
| Sponsor |
Technolas Perfect Vision GmbH
(industry)
|
Started 2013-10-01
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Primary completion 2014-02-01
Primary outcome
Effective Phacoemulsification Time
Secondary outcome
Adverse Events
Study completed - no results published.
This trial concluded in 2014 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov