Cleared Traditional

Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K213538) - FDA 510(k) Clearance

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

K213538 · Acuity Polymers, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
52d
Days
Class 2
Risk

K213538 is an FDA 510(k) clearance for the Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Cont.... 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 December 30, 2021 after a review of 52 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

Submission Details

510(k) Number K213538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2021
Decision Date December 30, 2021
Days to Decision 52 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
58d faster than avg
Panel avg: 110d · This submission: 52d
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 22
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K213538.
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)
K223394 · Visionary Optics, LLC · Dec 2022
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
K212631 · Contamac, Ltd. · Mar 2022
Custom Stable Rigid Gas Permeable Scleral Contact Lens
K213880 · Valley Contax, Inc. · Jan 2022
Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)
K202860 · Valley Contax, Inc. · May 2021
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K203571 · Acuity Polymers, Inc. · Apr 2021
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K201194 · Acuity Polymers, Inc. · Sep 2020