Cleared Special

Acuity 200? (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100? (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200? with Tangible? Hydra-PEG? (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100? with Tangible? Hydra-PEG? (hexafocon A) Rigid Gas Permeable Contact Lens

K240618 · Acuity Polymers, Inc. · Ophthalmic
Apr 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K240618 is an FDA 510(k) clearance for the Acuity 200? (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100? (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200? with Tangible? Hydra-PEG? (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100? with Tangible? Hydra-PEG? (hexafocon 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 April 3, 2024, 29 days after receiving the submission on March 5, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K240618 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2024
Decision Date April 03, 2024
Days to Decision 29 days
Submission Type Special
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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