Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens
FDA 510(k) K230965 · Acuity Polymers, Inc.
510(k) numberK230965
Submission
- Device name
- Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens
- Applicant
- Acuity Polymers, Inc.
Rochester, NY, US - Received
- April 5, 2023
- Decision date
- June 16, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQD – Lens, Contact (Other Material) - Daily
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5916
- Specialty
- Ophthalmic
Other 510(k)s with product code HQD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253822 | GPA (hexafocon A) Rigid Gas Permeable Contact LensesHQD · Traditional | Zhuhai Fitlens Medical Technology Co., Ltd. | 03/27/2026SE |
| K242393 | Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG®…HQD · Traditional | Acuity Polymers, Inc. | 11/01/2024SE |
| K241398 | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesHQD · Traditional | Tianjin Mastervision Technology Co., Ltd. | 10/22/2024SE |
| K241571 | BostonSight® Specialty LensesHQD · Traditional | Boston Foundation For Sight, Inc. D/B/A… | 08/14/2024SE |
| K240618 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon…HQD · Special | Acuity Polymers, Inc. | 04/03/2024SE |
| K233325 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…HQD · Traditional | Visionary Optics, LLC | 02/21/2024SE |
| K230910 | NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A)…HQD · Traditional | Acculens, Inc. | 06/16/2023SE |
| K221768 | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact LensesHQD · Traditional | Paragon Vision Sciences, Inc. | 05/05/2023SE |
| K223394 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…HQD · Special | Visionary Optics, LLC | 12/07/2022SE |
| K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact LensesHQD · Traditional | Contamac, Ltd. | 03/17/2022SE |
More from Contamac, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K242393 | Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG®…HQD · Traditional | 11/01/2024SE |
| K240618 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon…HQD · Special | 04/03/2024SE |
| K213538 | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensHQD · Traditional | 12/30/2021SE |
| K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensHQD · Traditional | 04/09/2021SE |
| K201194 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensHQD · Traditional | 09/08/2020SE |
| K180988 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B)…HQD · Abbreviated | 06/08/2018SE |
| K170001 | Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact LensHQD · Traditional | 06/02/2017SE |
| K170007 | Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact LensHQD · Traditional | 05/31/2017SE |
| K163254 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact LensHQD · Traditional | 01/18/2017SE |
| K162005 | Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensHQD · Traditional | 12/08/2016SE |
Questions and answers
When was Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens cleared by the FDA?
Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens (K230965) received a 510(k) decision of Substantially Equivalent on June 16, 2023, 72 days after the submission was received.
What is the product code of K230965?
The FDA product code is HQD – Lens, Contact (Other Material) - Daily, a Class II (moderate risk) device regulated under 21 CFR 886.5916.