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 Lens— 510(k) K180988

Substantially Equivalent

Acuity Polymers, Inc.

FDA 510(k) clearance K180988 for 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 Lens, Substantially Equivalent on 2018-06-08. Applicant: Acuity Polymers, Inc..

Clearance details

Applicant: Acuity Polymers, Inc.
Product code: Code HQD
Advisory panel: Ophthalmic
Date received: 2018-04-16
Decision date: 2018-06-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Rochester, NY, US

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