Facet Aurora Reusable Lancet Base— 510(k) K232912

Name: FDA 510(k) clearance K232912
Creator: U.S. Food and Drug Administration
Published: 2024-01-25

Substantially Equivalent

Facet Technologies, LLC

FDA 510(k) clearance K232912 for Facet Aurora Reusable Lancet Base, Substantially Equivalent on 2024-01-25. Applicant: Facet Technologies, LLC. Device class: 2.

Clearance details

Applicant: Facet Technologies, LLC
Product code: Code QRL
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2023-09-19
Decision date: 2024-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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K262135 — Lancing device2026-08-18
K262211 — Lancet2026-07-22
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K253706 — Lancing device (HH-XV-T)2025-12-09
K250813 — MICROLET®NEXT 2 Lancing Device2025-05-14

More clearances from Facet Technologies, LLC

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K223370 — NeatNick Heel Safety Lancet2023-02-13
K223099 — Facet Manatee Reusable Lancing Base2022-11-28
K222539 — Facet Blood Lancets2022-11-18
K221433 — Facet 28G Universal Lancet2022-07-15
K141749 — CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT2014-07-29

Adverse events under product code QRL

product code QRL

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.