LDE4 Lancing Device— 510(k) K222656
Substantially EquivalentI-Sens, Inc.
FDA 510(k) clearance K222656 for LDE4 Lancing Device, Substantially Equivalent on 2022-11-23. Applicant: I-Sens, Inc.. Device class: 2.
Clearance details
- Applicant
- I-Sens, Inc.
- Product code
- Code QRL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4850
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
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Adverse events under product code QRL
product code QRL- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.