Cleared Traditional

K221768 - Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses (FDA 510(k) Clearance)

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

K221768 · Paragon Vision Sciences, Inc. · Ophthalmic device
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May 2023
Decision
322d
Days
Class 2
Risk

K221768 is an FDA 510(k) clearance for the Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Paragon Vision Sciences, Inc. (Gilbert, US). The FDA issued a Cleared decision on May 5, 2023 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Paragon Vision Sciences, Inc. devices

Submission Details

510(k) Number K221768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2022
Decision Date May 05, 2023
Days to Decision 322 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
212d slower than avg
Panel avg: 110d · This submission: 322d
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 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 K221768.
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
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)
K233325 · Visionary Optics, LLC · Feb 2024