AVANT LASER— 510(k) K123474

Substantially Equivalent

Avant Wellness Systems, LLC

FDA 510(k) clearance K123474 for AVANT LASER, Substantially Equivalent on 2013-12-03. Applicant: Avant Wellness Systems, LLC.

Clearance details

Applicant: Avant Wellness Systems, LLC
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2012-11-13
Decision date: 2013-12-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: San Clemente, CA, 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.