LASER SYS*STIM 540, MODEL ME 540— 510(k) K043586

Name: FDA 510(k) clearance K043586
Creator: U.S. Food and Drug Administration
Published: 2005-05-06

Substantially Equivalent

Mettler Electronics Corp.

FDA 510(k) clearance K043586 for LASER SYS*STIM 540, MODEL ME 540, Substantially Equivalent on 2005-05-06. Applicant: Mettler Electronics Corp.. Device class: 2.

Clearance details

Applicant: Mettler Electronics Corp.
Product code: Code ILY
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2004-12-28
Decision date: 2005-05-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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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.