K201194 is an FDA 510(k) clearance for the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.
Submitted by Acuity Polymers, Inc. (Rochester, US). The FDA issued a Cleared decision on September 8, 2020 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 886.5916 - 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 Acuity Polymers, Inc. devices
NCT03971227
Completed
Interventional
Industry-sponsored
Clinical Evaluation of Acuity 200 (Fluoroxyfocon A) RGP Contact Lens
Clinical Evaluation of Safety and Effectiveness for the Acuity 200 (Fluoroxyfocon A) Rigid Gas Permeable Contact Lens
| Condition studied |
Refractive Errors |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
· Healthy volunteers accepted
|
| Principal investigator |
James A Bonafini, BS,MS |
| Sponsor |
Acuity Polymers, Inc.
(industry)
|
Started 2019-04-01
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Primary completion 2020-03-19
Primary outcome
Visual Acuity
Secondary outcome
Subjective Symptoms
Study completed - no results published.
This trial concluded in 2020 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510(k) Summary PDF or remain unpublished.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