HM-LAMP II— 510(k) K100234

Substantially Equivalent

Hillusa, Inc.

FDA 510(k) clearance K100234 for HM-LAMP II, Substantially Equivalent on 2010-07-08. Applicant: Hillusa, Inc..

Clearance details

Applicant: Hillusa, Inc.
Product code: Code FTD
Advisory panel: General, Plastic Surgery
Date received: 2010-01-26
Decision date: 2010-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FTD

product code FTD

Malfunction: 767
Total: 767

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.