Cleared Traditional

K213538 - Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (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
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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 117
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K213538.
GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
K253822 · Zhuhai Fitlens Medical Technology Co., Ltd. · Mar 2026
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K241571 · Boston Foundation For Sight, Inc. D/B/A Bostonsight · Aug 2024
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
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K233325 · Visionary Optics, LLC · Feb 2024