HQD · Class II · 21 CFR 886.5916

FDA Product Code HQD: Lens, Contact (other Material) - Daily

Leading manufacturers include Acuity Polymers, Inc., Contamac, Ltd. and Valley Contax, Inc..

118
Total
118
Cleared
109d
Avg days
1984
Since
Declining activity - 4 submissions in the last 2 years vs 6 in the prior period
Consistent review times: 108d avg (recent)

FDA 510(k) Cleared Lens, Contact (other Material) - Daily Devices (Product Code HQD)

118 devices
1–24 of 118
Cleared Mar 27, 2026
GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
K253822
Zhuhai Fitlens Medical Technology Co., Ltd.
Ophthalmic · 119d
Cleared Nov 01, 2024
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
K242393
Acuity Polymers, Inc.
Ophthalmic · 80d
Cleared Oct 22, 2024
SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
K241398
Tianjin Mastervision Technology Co., Ltd.
Ophthalmic · 159d
Cleared Aug 14, 2024
BostonSight® Specialty Lenses
K241571
Boston Foundation For Sight, Inc. D/B/A Bostonsight
Ophthalmic · 75d
Cleared Apr 03, 2024
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K240618
Acuity Polymers, Inc.
Ophthalmic · 29d
Cleared Feb 21, 2024
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)
K233325
Visionary Optics, LLC
Ophthalmic · 145d
Cleared Jun 16, 2023
NewVision SC (tisilfocon A) Scleral Lens
K230910
Acculens, Inc.
Ophthalmic · 77d
Cleared Jun 16, 2023
Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens
K230965
Acuity Polymers, Inc.
Ophthalmic · 72d
Cleared May 05, 2023
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
K221768
Paragon Vision Sciences, Inc.
Ophthalmic · 322d
Cleared Dec 07, 2022
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)
K223394
Visionary Optics, LLC
Ophthalmic · 29d
Cleared Mar 17, 2022
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
K212631
Contamac, Ltd.
Ophthalmic · 210d
Cleared Jan 07, 2022
Custom Stable Rigid Gas Permeable Scleral Contact Lens
K213880
Valley Contax, Inc.
Ophthalmic · 25d
Cleared Dec 30, 2021
Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K213538
Acuity Polymers, Inc.
Ophthalmic · 52d
Cleared May 11, 2021
Valley 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)
K202860
Valley Contax, Inc.
Ophthalmic · 225d
Cleared Apr 09, 2021
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K203571
Acuity Polymers, Inc.
Ophthalmic · 123d
Cleared Sep 08, 2020
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K201194
Acuity Polymers, Inc.
Ophthalmic · 127d
Cleared Feb 12, 2019
Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens
K183167
Bausch & Lomb, Incorporated
Ophthalmic · 89d
Cleared Jan 04, 2019
BostonSight Scleral
K183175
Bostonsight
Ophthalmic · 49d
Cleared Nov 23, 2018
Hyper GP (tisilfocon A) Daily Wear Contact Lens
K182304
Contamac, Ltd.
Ophthalmic · 91d
Cleared Jul 26, 2018
eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K
K181579
E&E Optics, Inc.
Ophthalmic · 41d
Cleared Jun 08, 2018
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
K180988
Acuity Polymers, Inc.
Ophthalmic · 53d
Cleared Apr 25, 2018
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens
K180616
Contamac, Ltd.
Ophthalmic · 48d
Cleared Mar 16, 2018
FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG
K180172
Paragon Vision Sciences
Ophthalmic · 53d

About Product Code HQD - Regulatory Context

510(k) Submission Activity

118 total 510(k) submissions under product code HQD since 1984, with 118 receiving FDA clearance (average review time: 109 days).

Submission volume has declined in recent years - 4 submissions in the last 24 months compared to 6 in the prior period.

FDA 510(k) Review Time - HQD Product Code

FDA review times for HQD submissions have been consistent, averaging 108 days recently vs 109 days historically.

HQD devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →