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FDA 510(k)

MENICON Z

K-Number: K000133 · 2000-05-19

ApplicantMenicon U.S.A., Inc.
Decision Date2000-05-19
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MENICON Z is the device name listed in this FDA 510(k) record. The listed applicant is Menicon U.S.A., Inc.. It received FDA 510(k) clearance on 2000-05-19 under 510(k) number K000133. 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 MENICON Z?

MENICON Z is a medical device that received FDA 510(k) clearance on 2000-05-19. The listed applicant is Menicon U.S.A., Inc.. The 510(k) number is K000133.

When did MENICON Z receive FDA 510(k) clearance?

MENICON Z received FDA 510(k) clearance on 2000-05-19, under 510(k) number K000133.

Who is the listed applicant for MENICON Z?

The FDA 510(k) record lists Menicon U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MENICON Z?

The FDA product code for MENICON Z 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Menicon U.S.A., Inc. as applicant

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.

K972443MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENSK970019MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS

Related Devices (Code: HQD)

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.

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.K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A BostonsightK240618Acuity 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

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.

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