510(k) K202055— Looper (Model: ZX-579S)

Substantially Equivalent

Heat IN A Click, LLC

Clearance details

Applicant
Heat IN A Click, LLC
Product code
Code OLP
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Homestead, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code OLP

product code OLP
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.