FDA 510(k)

Facet Blood Lancets

K-Number: K222539 · 2022-11-18

Decision Date2022-11-18

Product CodeQRL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Facet Blood Lancets is a medical device manufactured by Facet Technologies, LLC. It received FDA 510(k) clearance on 2022-11-18 under approval number K222539. 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 Facet Blood Lancets?

Facet Blood Lancets is a medical device that received FDA 510(k) clearance on 2022-11-18. It is manufactured by Facet Technologies, LLC. The 510(k) number is K222539.

When was Facet Blood Lancets approved by the FDA?

Facet Blood Lancets received FDA 510(k) clearance on 2022-11-18, under approval number K222539.

What company makes Facet Blood Lancets?

Facet Blood Lancets is manufactured by Facet Technologies, LLC.

What is the FDA product code for Facet Blood Lancets?

The FDA product code for Facet Blood Lancets is QRL.

Other Devices by Facet Technologies, LLC

K223099Facet Manatee Reusable Lancing Base K221433Facet 28G Universal Lancet K223370NeatNick Heel Safety Lancet K232912Facet Aurora Reusable Lancet Base

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 K222656LDE4 Lancing DeviceI-Sens, Inc. K222246Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd. K221072TRUEdraw Lancing Device, Mini Lancing DeviceTrividia Health K221175Multi-Lancet Device 2, ReliOn Premier Lancing DeviceArkray, 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.