FDA 510(k)

Facet Aurora Reusable Lancet Base

K-Number: K232912 · 2024-01-25

Decision Date2024-01-25

Product CodeQRL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Facet Aurora Reusable Lancet Base is a medical device manufactured by Facet Technologies, LLC. It received FDA 510(k) clearance on 2024-01-25 under approval number K232912. 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 Aurora Reusable Lancet Base?

Facet Aurora Reusable Lancet Base is a medical device that received FDA 510(k) clearance on 2024-01-25. It is manufactured by Facet Technologies, LLC. The 510(k) number is K232912.

When was Facet Aurora Reusable Lancet Base approved by the FDA?

Facet Aurora Reusable Lancet Base received FDA 510(k) clearance on 2024-01-25, under approval number K232912.

What company makes Facet Aurora Reusable Lancet Base?

Facet Aurora Reusable Lancet Base is manufactured by Facet Technologies, LLC.

What is the FDA product code for Facet Aurora Reusable Lancet Base?

The FDA product code for Facet Aurora Reusable Lancet Base is QRL.

Other Devices by Facet Technologies, LLC

K223099Facet Manatee Reusable Lancing Base K222539Facet Blood Lancets K221433Facet 28G Universal Lancet K223370NeatNick Heel Safety Lancet

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. K222539Facet Blood LancetsFacet Technologies, LLC K221072TRUEdraw Lancing Device, Mini Lancing DeviceTrividia Health

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.