Acuity

Basic Information

• Brand Name: Acuity
• Primary DI: 00850203008330
• Version / Model: 181
• Company Name: ACUITY POLYMERS, INC.
• Labeler DUNS: 045438768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-09
• Public Version: 2
• Public Version Date: 2026-03-17
• Public Version Status: Update
• Public Device Record Key: c435caed-b955-49b4-bbbb-a7733b63ae00

Device Description

Rigid-gas-permeable contact lens - daily wear tisilfocon A

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Liquid Chemical

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	886.5916	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47840	Rigid-gas-permeable corrective contact lens, daily-wear, non-customized	A prefabricated (non-customized) rigid ophthalmic lens intended to be worn directly against the cornea of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be removed prior to sleeping each night. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850203008330	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K163254	000