MEDILASER, MODEL 1000— 510(k) K063745

Substantially Equivalent

Laser Thera, LLC

FDA 510(k) clearance K063745 for MEDILASER, MODEL 1000, Substantially Equivalent on 2007-04-23. Applicant: Laser Thera, LLC.

Clearance details

Applicant: Laser Thera, LLC
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2006-12-19
Decision date: 2007-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, 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.