510(k) K223147— myLEDmask

Substantially Equivalent

Myblend

Clearance details

Applicant: Myblend
Product code: Code OHS
Advisory panel: General, Plastic Surgery
Date received: 2022-10-05
Decision date: 2023-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neuilly-Sur-Seine, FR

Adverse events under product code OHS

product code OHS

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.