Cleared Traditional

K163254 - Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens

K163254 is an FDA 510(k) clearance for Acuity 18 (enflufocon A) Rigid Gas Perm..., manufactured by Acuity Polymers, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K163254 · Acuity Polymers, Inc. · Ophthalmic device
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Jan 2017
Decision
58d
Days
Class 2
Risk

K163254 is an FDA 510(k) clearance for the Acuity 18 (enflufocon 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 January 18, 2017 after a review of 58 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Acuity Polymers, Inc. devices

FDA 510(k) Submission Details - K163254

510(k) Number K163254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2016
Decision Date January 18, 2017
Days to Decision 58 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
52d faster than avg
Panel avg: 110d · This submission: 58d
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 108
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