ACUMED LASER, MODEL 1000— 510(k) K060153

Substantially Equivalent

Laser Thera, LLC

FDA 510(k) clearance K060153 for ACUMED LASER, MODEL 1000, Substantially Equivalent on 2006-09-29. Applicant: Laser Thera, LLC.

Clearance details

Applicant: Laser Thera, LLC
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2006-01-20
Decision date: 2006-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yukon, OK, US

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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.