mint Lesion— 510(k) K142647
Substantially EquivalentMint Medical GmbH
FDA 510(k) clearance K142647 for mint Lesion, Substantially Equivalent on 2015-04-13. Applicant: Mint Medical GmbH. Device class: 2.
Clearance details
- Applicant
- Mint Medical GmbH
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dossenheim, DE
Recent devices under product code LLZ
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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 →
Recalls naming K142647
K-number listed on FDA's recall record- Z-0709-2025 — mint Lesion, Software Versions: 3.9.0 through 3.9.5.
- Z-0710-2025 — mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142647.
Data sourced from openFDA. This site is unofficial and independent of the FDA.