GIGALASER— 510(k) K134017

Substantially Equivalent

Powermedic Aps

FDA 510(k) clearance K134017 for GIGALASER, Substantially Equivalent on 2014-05-02. Applicant: Powermedic Aps.

Clearance details

Applicant: Powermedic Aps
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2013-12-30
Decision date: 2014-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.