CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55.— 510(k) K052647

Substantially Equivalent

American Spine Center, Ltd.

FDA 510(k) clearance K052647 for CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55., Substantially Equivalent on 2005-11-09. Applicant: American Spine Center, Ltd..

Clearance details

Applicant: American Spine Center, Ltd.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2005-09-26
Decision date: 2005-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belleville, IL, 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.