HQD · Lens, Contact (Other Material) - Daily
Ophthalmic · 21 CFR 886.5916 · Class 2
Overview
| Product Code | HQD |
|---|---|
| Device Name | Lens, Contact (Other Material) - Daily |
| Regulation | 21 CFR 886.5916 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.
Classification Rationale
(1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
Recent Cleared Devices (20 of 120)
Showing 20 most recent of 120 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253822 | GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | Zhuhai Fitlens Medical Technology Co., Ltd. | Mar 27, 2026 | SESE |
| K242393 | Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses | Acuity Polymers, Inc. | Nov 1, 2024 | SESE |
| K241398 | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses | Tianjin Mastervision Technology Co., Ltd. | Oct 22, 2024 | SESE |
| K241571 | BostonSight® Specialty Lenses | Boston Foundation For Sight, Inc. D/B/A Bostonsight | Aug 14, 2024 | SESE |
| K240618 | 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® (hexafocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | Apr 3, 2024 | SESE |
| K233325 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) | Visionary Optics, LLC | Feb 21, 2024 | SESE |
| K230965 | Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | Jun 16, 2023 | SESE |
| K230910 | NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens | Acculens, Inc. | Jun 16, 2023 | SESE |
| K221768 | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | Paragon Vision Sciences, Inc. | May 5, 2023 | SESE |
| K223394 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) | Visionary Optics, LLC | Dec 7, 2022 | SESE |
| K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | Contamac, Ltd. | Mar 17, 2022 | SESE |
| K213880 | Custom Stable Rigid Gas Permeable Scleral Contact Lens | Valley Contax, Inc. | Jan 7, 2022 | SESE |
| K213538 | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | Dec 30, 2021 | SESE |
| K202860 | 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) | Valley Contax, Inc. | May 11, 2021 | SESE |
| K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | Apr 9, 2021 | SESE |
| K201194 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | Sep 8, 2020 | SESE |
| K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens | Bausch & Lomb, Incorporated | Feb 12, 2019 | SESE |
| K183175 | BostonSight Scleral | Bostonsight | Jan 4, 2019 | SESE |
| K182304 | Hyper GP (tisilfocon A) Daily Wear Contact Lens | Contamac, Ltd. | Nov 23, 2018 | SESE |
| K181579 | eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K | E&E Optics, Inc. | Jul 26, 2018 | SESE |
Top Applicants
- Acuity Polymers, Inc. — 11 clearances
- Contamac, Ltd. — 11 clearances
- Paragon Vision Sciences — 10 clearances
- Synergeyes, Inc. — 9 clearances
- Menicon Co, Ltd. — 5 clearances
