Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens— 510(k) K170007

Name: FDA 510(k) clearance K170007
Creator: U.S. Food and Drug Administration
Published: 2017-05-31

Substantially Equivalent

Acuity Polymers, Inc.

FDA 510(k) clearance K170007 for Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens, Substantially Equivalent on 2017-05-31. 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: 2017-01-03
Decision date: 2017-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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