Cleared Traditional

Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens

K213538 · Acuity Polymers, Inc. · Ophthalmic
Dec 2021
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K213538 is an FDA 510(k) clearance for the Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Acuity Polymers, Inc. (Rochester, US). The FDA issued a Cleared decision on December 30, 2021, 52 days after receiving the submission on November 8, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K213538 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HQD — Lens, Contact (other Material) - Daily
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5916

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