Cleared Traditional

K233325 - Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233325 · Visionary Optics, LLC · Ophthalmic device
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Feb 2024
Decision
145d
Days
Class 2
Risk

K233325 is an FDA 510(k) clearance for the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon .... Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Visionary Optics, LLC (Front Royal, US). The FDA issued a Cleared decision on February 21, 2024 after a review of 145 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 Visionary Optics, LLC devices

Submission Details

510(k) Number K233325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date February 21, 2024
Days to Decision 145 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 110d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQD Lens, Contact (other Material) - Daily
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5916
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Andrew Vision and Device Research
Bret Andre

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HQD Lens, Contact (other Material) - Daily

All 117
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K233325.
GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
K253822 · Zhuhai Fitlens Medical Technology Co., Ltd. · Mar 2026
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
K242393 · Acuity Polymers, Inc. · Nov 2024
SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
K241398 · Tianjin Mastervision Technology Co., Ltd. · Oct 2024
BostonSight® Specialty Lenses
K241571 · Boston Foundation For Sight, Inc. D/B/A Bostonsight · Aug 2024
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K240618 · Acuity Polymers, Inc. · Apr 2024
NewVision SC (tisilfocon A) Scleral Lens
K230910 · Acculens, Inc. · Jun 2023