Silhouette Featherlift / Silhouette Lift— 510(k) K191299

Substantially Equivalent

Silhouette Lift, Inc.

FDA 510(k) clearance K191299 for Silhouette Featherlift / Silhouette Lift, Substantially Equivalent on 2019-06-14. Applicant: Silhouette Lift, Inc..

Clearance details

Applicant
Silhouette Lift, Inc.
Product code
Code GAW
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GAW

product code GAW
Death
66
Injury
1,616
Malfunction
10,428
Total
12,110

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.