FDA.reportPublic FDA data

510(k) K240618

Device
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
Applicant
Acuity Polymers, Inc.
510(k) number
K240618
Product code
HQD
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-03
Date received
2024-03-05
Regulation
886.5916
Classification name
Lens, Contact (Other Material) - Daily
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
James A. Bonafini
Address
1667 Lake Ave., Suite 354 Rochester NY US 14615 14615

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HQD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.2026-03-27
K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensesAcuity Polymers, Inc.2024-11-01
K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.2024-10-22
K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight2024-08-14
K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC2024-02-21
K230965Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensAcuity Polymers, Inc.2023-06-16
K230910NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral LensAcculens, Inc.2023-06-16
K221768Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact LensesParagon Vision Sciences, Inc.2023-05-05
K223394Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)Visionary Optics, LLC2022-12-07
K212631Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd.2022-03-17
K213880Custom Stable Rigid Gas Permeable Scleral Contact LensValley Contax, Inc.2022-01-07
K213538Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.2021-12-30
K202860Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)Valley Contax, Inc.2021-05-11
K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.2021-04-09
K201194Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.2020-09-08