NEUROLASE, MODELS 150V, 150C, 1064— 510(k) K032787

Substantially Equivalent

Spectrum Laser & Technologies

FDA 510(k) clearance K032787 for NEUROLASE, MODELS 150V, 150C, 1064, Substantially Equivalent on 2003-11-20. Applicant: Spectrum Laser & Technologies.

Clearance details

Applicant: Spectrum Laser & Technologies
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2003-09-08
Decision date: 2003-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, 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.