FDA.reportPublic FDA data

510(k) K253822

Device
GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
Applicant
Zhuhai Fitlens Medical Technology Co., Ltd.
510(k) number
K253822
Product code
HQD
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-27
Date received
2025-11-28
Regulation
886.5916
Classification name
Lens, Contact (Other Material) - Daily
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Grace Wang
Address
Bldg. 6, # 129, Dingxing Rd., Tangjiawan Town High-Tech Zone Zhuhai CN 519080 519080

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
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
K240618Acuity 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 LensAcuity Polymers, Inc.2024-04-03
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