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FDA 510(k)

OptiScanner® 5000 Glucose Monitoring System

K-Number: K192785 · 2020-02-05

ApplicantOptiscan Biomedical Corporation
Decision Date2020-02-05
Product CodeLZF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OptiScanner® 5000 Glucose Monitoring System is a medical device manufactured by Optiscan Biomedical Corporation. It received FDA 510(k) clearance on 2020-02-05 under approval number K192785. The device is classified under product code LZF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptiScanner® 5000 Glucose Monitoring System?

OptiScanner® 5000 Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2020-02-05. It is manufactured by Optiscan Biomedical Corporation. The 510(k) number is K192785.

When was OptiScanner® 5000 Glucose Monitoring System approved by the FDA?

OptiScanner® 5000 Glucose Monitoring System received FDA 510(k) clearance on 2020-02-05, under approval number K192785.

What company makes OptiScanner® 5000 Glucose Monitoring System?

OptiScanner® 5000 Glucose Monitoring System is manufactured by Optiscan Biomedical Corporation.

What is the FDA product code for OptiScanner® 5000 Glucose Monitoring System?

The FDA product code for OptiScanner® 5000 Glucose Monitoring System is LZF.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07599982 Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes RECRUITING NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41964171 Journal of diabetes science and technology (2026) PMID: 41760572 Trends in use of continuous glucose monitors among individuals with type 2 diabetes enrolled in Medicare Advantage (2021-2023). Journal of managed care & specialty pharmacy (2026)

Related Devices (Code: LZF)

K162042OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical Corp.

Official Source

View on FDA Database →

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

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