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FDA 510(k)

LDE4 Lancing Device

K-Number: K222656 · 2022-11-23

ApplicantI-Sens, Inc.
Decision Date2022-11-23
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LDE4 Lancing Device is a medical device manufactured by I-Sens, Inc.. It received FDA 510(k) clearance on 2022-11-23 under approval number K222656. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LDE4 Lancing Device?

LDE4 Lancing Device is a medical device that received FDA 510(k) clearance on 2022-11-23. It is manufactured by I-Sens, Inc.. The 510(k) number is K222656.

When was LDE4 Lancing Device approved by the FDA?

LDE4 Lancing Device received FDA 510(k) clearance on 2022-11-23, under approval number K222656.

What company makes LDE4 Lancing Device?

LDE4 Lancing Device is manufactured by I-Sens, Inc..

What is the FDA product code for LDE4 Lancing Device?

The FDA product code for LDE4 Lancing Device is QRL.

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Related Devices (Code: QRL)

K222472Lancing System, Sterile Lancet for Single Use, Lancing DeviceShandong Lianfa Medical Plastic Products Co. , Ltd. K223099Facet Manatee Reusable Lancing BaseFacet Technologies, LLC K222246Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd. K222539Facet Blood LancetsFacet Technologies, LLC K221072TRUEdraw Lancing Device, Mini Lancing DeviceTrividia Health K221175Multi-Lancet Device 2, ReliOn Premier Lancing DeviceArkray, Inc.

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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