HQD — Lens, Contact (Other Material) - Daily Class II

FDA Device Classification

Classification Details

Product Code
HQD
Device Class
Class II
Regulation Number
886.5916
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242393acuity polymersAcuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PNovember 1, 2024
K241398tianjin mastervision technology coSDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesOctober 22, 2024
K241571boston foundation for sight, inc. d/b/a bostonsightBostonSight® Specialty LensesAugust 14, 2024
K240618acuity polymersAcuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexApril 3, 2024
K233325visionary opticsVisionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, February 21, 2024
K230910acculensNewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilJune 16, 2023
K230965acuity polymersAcuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with TJune 16, 2023
K221768paragon vision sciencesOxfore®100 (hexafocon A) Rigid Gas Permeable Contact LensesMay 5, 2023
K223394visionary opticsVisionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, December 7, 2022
K212631contamacOptimum Infinite (tisilfocon A) Daily Wear Contact LensesMarch 17, 2022
K213880valley contaxCustom Stable Rigid Gas Permeable Scleral Contact LensJanuary 7, 2022
K213538acuity polymersAcuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable ContactDecember 30, 2021
K202860valley contaxValley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, rofluMay 11, 2021
K203571acuity polymersAcuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensApril 9, 2021
K201194acuity polymersAcuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensSeptember 8, 2020
K183167bausch and lomb, incorporatedBoston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufoconFebruary 12, 2019
K183175bostonsightBostonSight ScleralJanuary 4, 2019
K182304contamacHyper GP (tisilfocon A) Daily Wear Contact LensNovember 23, 2018
K181579e and e opticseLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas PermeableJuly 26, 2018
K180988acuity polymersAcuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufoconJune 8, 2018