Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens +3 more— 510(k) K240618

Clearance details

Device name as filed

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

Applicant

Acuity Polymers, Inc.

Product code

Code HQD

Device class

Class 2

Regulation

21 CFR 886.5916

Advisory panel

Ophthalmic

Date received

2024-03-05

Decision date

2024-04-03

Decision

Substantially Equivalent

Clearance type

Special

Location

Rochester, NY, US

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