HQD — Lens, Contact (Other Material) - Daily Class II
FDA product code HQD covers "Lens, Contact (Other Material) - Daily", a Class II medical device regulated under 21 CFR 886.5916. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253822 | zhuhai fitlens medical technology co | GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | March 27, 2026 |
| K242393 | acuity polymers | Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-P | November 1, 2024 |
| K241398 | tianjin mastervision technology co | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses | October 22, 2024 |
| K241571 | boston foundation for sight, inc. d/b/a bostonsight | BostonSight® Specialty Lenses | August 14, 2024 |
| K240618 | acuity polymers | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hex | April 3, 2024 |
| K233325 | visionary optics | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, | February 21, 2024 |
| K230910 | acculens | NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisil | June 16, 2023 |
| K230965 | acuity polymers | Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with T | June 16, 2023 |
| K221768 | paragon vision sciences | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | May 5, 2023 |
| K223394 | visionary optics | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, | December 7, 2022 |
| K212631 | contamac | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | March 17, 2022 |
| K213880 | valley contax | Custom Stable Rigid Gas Permeable Scleral Contact Lens | January 7, 2022 |
| K213538 | acuity polymers | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact | December 30, 2021 |
| K202860 | valley contax | Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflu | May 11, 2021 |
| K203571 | acuity polymers | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | April 9, 2021 |
| K201194 | acuity polymers | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | September 8, 2020 |
| K183167 | bausch and lomb, incorporated | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon | February 12, 2019 |
| K183175 | bostonsight | BostonSight Scleral | January 4, 2019 |
| K182304 | contamac | Hyper GP (tisilfocon A) Daily Wear Contact Lens | November 23, 2018 |
| K181579 | e and e optics | eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable | July 26, 2018 |