K160344 is an FDA 510(k) clearance for the Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olif.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.
Submitted by Visco Vision, Inc. (Taoyuan City, TW). The FDA issued a Cleared decision on May 26, 2016 after a review of 108 days - within the typical 510(k) review window.
This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - 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 Visco Vision, Inc. devices
NCT02676258
Completed
Interventional
Industry-sponsored
Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens
A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of Si-Hy Silicone Hydrogel Soft Contact Lens
| Condition studied |
Myopia |
| Study design |
Parallel |
| Eligibility |
All sexes
· 20 Years+
|
| Principal investigator |
Huey Chuan Cheng, MD MS |
| Sponsor |
Visco Vision Inc.
(industry)
|
Started 2015-06-01
→
Primary completion 2015-11-01
Primary outcome
Visual Acuity
Secondary outcome
Any Slit Lamp Finding > Grade 2
Study completed - no results published.
This trial concluded in 2015 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510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov