Cleared Traditional

K221768 - Oxfore100 (hexafocon A) Rigid Gas Perme...

K221768 is an FDA 510(k) clearance for Oxfore100 (hexafocon A) Rigid Gas Perme..., manufactured by Paragon Vision Sciences, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 322-day FDA review.

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

FDA 510(k) Submission Details - K221768

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.

HQD Device Classification - Class 2, Special Controls

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 33
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