Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens— 510(k) K213538

Substantially Equivalent

Acuity Polymers, Inc.

FDA 510(k) clearance K213538 for Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, Substantially Equivalent on 2021-12-30. Applicant: Acuity Polymers, Inc..

Clearance details

Applicant: Acuity Polymers, Inc.
Product code: Code HQD
Advisory panel: Ophthalmic
Date received: 2021-11-08
Decision date: 2021-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.