Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
FDA 510(k) K221768 · Paragon Vision Sciences, Inc.
510(k) numberK221768
Submission
- Device name
- Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
- Applicant
- Paragon Vision Sciences, Inc.
Gilbert, AZ, US - Received
- June 17, 2022
- Decision date
- May 5, 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 |
| K230965 | Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible…HQD · Traditional | Acuity Polymers, Inc. | 06/16/2023SE |
| K230910 | NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A)…HQD · Traditional | Acculens, Inc. | 06/16/2023SE |
| 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 |
|---|---|---|
| K180172 | FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG…HQD · Traditional | 03/16/2018SE |
| K120996 | Fluoroperm 30 Paragon HDS Fluoroperm 60 Paragon HDS 100 Fluoroperm 92 Fluoroperm 151…HQD · Traditional | 06/28/2012SE |
| K082799 | HDS Hi 1.54HQD · Traditional | 01/27/2009SE |
| K070637 | Fluoroperm 92, 60, 30 and 151 and Paragon HDS, HDS 100 and Thin Rigid Gas Permeable…HQD · Traditional | 05/01/2007SE |
| K052983 | Fluoroperm 151 (Paflufocon D) and Paragon HDS 100 (Paflufocon D) Rigid Gas Permeable…HQD · Traditional | 02/10/2006SE |
| K013310 | PVS Basic 2; Epic 2HQD · Traditional | 04/25/2002SE |
| K010109 | Fluoroperm 151-OK, Paragon HDS 100-OKMUW · Traditional | 02/28/2001SESU |
| K002845 | Paflufocon C and E Daily Contact LensHQD · Traditional | 12/08/2000SE |
| K993586 | Sportsight GPHQD · Traditional | 05/22/2000SE |
| K000224 | Fluroperm 60-OK, Paragon Hds-OkMUW · Traditional | 04/17/2000SESU |
Questions and answers
When was Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses cleared by the FDA?
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses (K221768) received a 510(k) decision of Substantially Equivalent on May 5, 2023, 322 days after the submission was received.
What is the product code of K221768?
The FDA product code is HQD – Lens, Contact (Other Material) - Daily, a Class II (moderate risk) device regulated under 21 CFR 886.5916.