Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens— 510(k) K163254

Name: FDA 510(k) clearance K163254
Creator: U.S. Food and Drug Administration
Published: 2017-01-18

Substantially Equivalent

Acuity Polymers, Inc.

FDA 510(k) clearance K163254 for Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Substantially Equivalent on 2017-01-18. Applicant: Acuity Polymers, Inc.. Device class: 2.

Clearance details

Applicant: Acuity Polymers, Inc.
Product code: Code HQD
Device class: Class 2
Regulation: 21 CFR 886.5916
Advisory panel: Ophthalmic
Date received: 2016-11-21
Decision date: 2017-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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K203571 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens2021-04-09
K201194 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens2020-09-08
K180988 — Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens2018-06-08

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