Cleared Abbreviated

K180988 - Acuity 18 (enflufocon A) Rigid Gas Perm...

K180988 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 Abbreviated 510(k) pathway after a 53-day FDA review.

K180988 · Acuity Polymers, Inc. · Ophthalmic device
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Jun 2018
Decision
53d
Days
Class 2
Risk

K180988 is an FDA 510(k) clearance for the Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufo.... 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 June 8, 2018 after a review of 53 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Acuity Polymers, Inc. devices

FDA 510(k) Submission Details - K180988

510(k) Number K180988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2018
Decision Date June 08, 2018
Days to Decision 53 days
Submission Type Abbreviated
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
57d faster than avg
Panel avg: 110d · This submission: 53d
Pathway characteristics
Standards-based clearance path.

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
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K180988.
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