Panels › Ophthalmic › Product code HQD · Class 2
Lens, Contact (Other Material) - Daily
Regulation 886.5916
1510(k)s in 12 months (118 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in HQD
| Company | 510(k)s | Recalls |
|---|---|---|
| Acuity Polymers, Inc. | 11 | 0 |
| Contamac, Ltd. | 11 | 0 |
| Paragon Vision Sciences | 11 | 0 |
| Synergeyes | 11 | 0 |
| Bausch & Lomb, Inc. | 8 | 1 |
| Polymer Technology | 8 | 0 |
| Menicon Co, Ltd. | 7 | 0 |
| Boston Foundation For Sight | 1 | 2 |
| Innovision, Inc. | 3 | 0 |
| The Lagado Corp. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 27, 2026 | K253822 | GPA (hexafocon A) Rigid Gas Permeable Contact Lenses Zhuhai Fitlens Medical Technology Co., Ltd., CN | HQD |
| Nov 1, 2024 | K242393 | Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses Acuity Polymers, Inc. | HQD |
| Oct 22, 2024 | K241398 | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses Tianjin Mastervision Technology Co., Ltd., CN | HQD |
| Aug 14, 2024 | K241571 | BostonSight® Specialty Lenses Boston Foundation For Sight, Inc. D/B/A Bostonsight | HQD |
| Apr 3, 2024 | K240618 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Le Acuity Polymers, Inc. | HQD |
| Feb 21, 2024 | K233325 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon Visionary Optics, LLC | HQD |
| Jun 16, 2023 | K230965 | Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Acuity Polymers, Inc. | HQD |
| Jun 16, 2023 | K230910 | NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens Acculens, Inc. | HQD |
| May 5, 2023 | K221768 | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses Paragon Vision Sciences, Inc. | HQD |
| Dec 7, 2022 | K223394 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) Visionary Optics, LLC | HQD |
| Mar 17, 2022 | K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses Contamac, Ltd., GB | HQD |
| Jan 7, 2022 | K213880 | Custom Stable Rigid Gas Permeable Scleral Contact Lens Valley Contax, Inc. | HQD |
| Dec 30, 2021 | K213538 | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. | HQD |
| May 11, 2021 | K202860 | Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enfl Valley Contax, Inc. | HQD |
| Apr 9, 2021 | K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. | HQD |
| Sep 8, 2020 | K201194 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. | HQD |
| Feb 12, 2019 | K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Bo Bausch & Lomb, Incorporated | HQD |
| Jan 4, 2019 | K183175 | BostonSight Scleral Bostonsight | HQD |
| Nov 23, 2018 | K182304 | Hyper GP (tisilfocon A) Daily Wear Contact Lens Contamac, Ltd., GB | HQD |
| Jul 26, 2018 | 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. | HQD |
| Jun 8, 2018 | K180988 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Ac Acuity Polymers, Inc. | HQD |
| Apr 25, 2018 | K180616 | OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens Contamac, Ltd., GB | HQD |
| Mar 16, 2018 | K180172 | FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paf Paragon Vision Sciences | HQD |
| Oct 24, 2017 | K171575 | ENFLU 18 (enflufocon A) Daily Wear Contact Lens Contamac, Ltd., GB | HQD |
| Sep 20, 2017 | K172314 | Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) Art Optical Contact Lens, Inc. | HQD |
| Aug 16, 2017 | K171950 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) Visionary Optics, LLC | HQD |
| Aug 1, 2017 | K171077 | HEXA100 (hexafocon A) Daily Wear Contact Lenses Contamac, Ltd., GB | HQD |
| Jul 17, 2017 | K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) Bausch + Lomb, Incorporated | HQD |
| Jun 2, 2017 | K170001 | Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. | HQD |
| May 31, 2017 | K170007 | Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. | HQD |
| Mar 24, 2017 | K170335 | Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens Valley Contax, Inc. | HQD |
| Jan 18, 2017 | K163254 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. | HQD |
| Dec 8, 2016 | K162005 | Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. | HQD |
| Nov 15, 2016 | K153714 | SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilco Synergeyes, Inc. | HQD |
| Aug 10, 2016 | K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses Contamac, Ltd., GB | HQD |
| Aug 1, 2016 | K160938 | SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens Synergeyes, Inc. | HQD |
| Jul 25, 2016 | K161461 | BostonSight PD Prosthetic Device Bostonsight | HQD |
| Apr 27, 2016 | K152724 | EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES Advanced Vision Technologies | HQD |
| Feb 9, 2016 | K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens Boston Foundation For Sight | HQD |
| Nov 19, 2014 | K142510 | UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens Synergeyes, Inc. | HQD |
| Jun 28, 2012 | K120996 | FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN Paragon Vision Sciences | HQD |
| Apr 18, 2012 | K113586 | SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS Synergeyes, Inc. | HQD |
| Feb 3, 2011 | K103561 | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS Menicon Co, Ltd. | HQD |
| Jan 21, 2011 | K102154 | TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS The Lagado Corp. | HQD |
| May 20, 2009 | K083921 | SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS Synergeyes, Inc. | HQD |
| Jan 27, 2009 | K082799 | HDS HI 1.54 Paragon Vision Sciences | HQD |
| Oct 9, 2008 | K081178 | OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES Contamac, Ltd. | HQD |
| Sep 23, 2008 | K081443 | MENICON Z RIGID GAS PERMEABLE CONTACT LENS Menicon Co, Ltd. | HQD |
| May 30, 2008 | K081034 | SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS Synergeyes, Inc. | HQD |
| Mar 5, 2008 | K080193 | SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR Synergeyes, Inc. | HQD |
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