LDE4 Lancing Device— 510(k) K222656

Substantially Equivalent

I-Sens, Inc.

FDA 510(k) clearance K222656 for LDE4 Lancing Device, Substantially Equivalent on 2022-11-23. Applicant: I-Sens, Inc..

Clearance details

Applicant: I-Sens, Inc.
Product code: Code QRL
Advisory panel: General, Plastic Surgery
Date received: 2022-09-02
Decision date: 2022-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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.