Cleared Traditional

K170007 - Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens

K170007 is an FDA 510(k) clearance for Acuity 58 (Enflufocon B) 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 148-day FDA review.

K170007 · Acuity Polymers, Inc. · Ophthalmic device
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May 2017
Decision
148d
Days
Class 2
Risk

K170007 is an FDA 510(k) clearance for the Acuity 58 (Enflufocon B) 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 May 31, 2017 after a review of 148 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 Acuity Polymers, Inc. devices

FDA 510(k) Submission Details - K170007

510(k) Number K170007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2017
Decision Date May 31, 2017
Days to Decision 148 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
38d slower than avg
Panel avg: 110d · This submission: 148d
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
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K170007.
HEXA100 (hexafocon A) Daily Wear Contact Lenses
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K170335 · Valley Contax, Inc. · Mar 2017
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K162005 · Acuity Polymers, Inc. · Dec 2016