K191397 is an FDA 510(k) clearance for the OxySoft (olifilcon C) silicone hydrogel soft contact lens. 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 October 2, 2019 after a review of 131 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
NCT03934788
Completed
Interventional
Industry-sponsored
the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens
A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of OxySoft Silicone Hydrogel Soft Contact Lens
| Condition studied |
Myopia |
| Study design |
Parallel |
| Eligibility |
All sexes
· 20 Years+
|
| Principal investigator |
Huey Chuan Cheng, MD MSc |
| Sponsor |
Visco Vision Inc.
(industry)
|
Started 2018-09-26
→
Primary completion 2018-11-29
Primary outcome
Log MAR visual acuities
Secondary outcome
slit lamp findings
Study completed - no results published.
This trial concluded in 2018 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510(k) Summary PDF or remain unpublished.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