FDA 510(k)

SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses

K-Number: K241398 · 2024-10-22

ApplicantTianjin Mastervision Technology Co., Ltd.

Decision Date2024-10-22

Product CodeHQD

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Mastervision Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-10-22 under 510(k) number K241398. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses?

SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses is a medical device that received FDA 510(k) clearance on 2024-10-22. The listed applicant is Tianjin Mastervision Technology Co., Ltd.. The 510(k) number is K241398.

When did SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses receive FDA 510(k) clearance?

SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses received FDA 510(k) clearance on 2024-10-22, under 510(k) number K241398.

Who is the listed applicant for SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses?

The FDA 510(k) record lists Tianjin Mastervision Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses?

The FDA product code for SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses is HQD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07494799Efficacy of Different Interventions for Progressive Myopia After Orthokeratology Lens WearNOT_YET_RECRUITING NCT07288658Comparing the Fit and Performance of Scleral Lenses With Oval and Circular Limbal ZonesCOMPLETED

Other records listing Tianjin Mastervision Technology Co., Ltd. as applicant

PMA P220015Lens, contact, orthokeratology, overnight

Related Devices (Code: HQD)

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensesAcuity Polymers, Inc.K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight K240618Acuity 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 LensAcuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC K230965Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensAcuity Polymers, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.