COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT— 510(k) K041679

Substantially Equivalent

Onyx Medical, Inc.

FDA 510(k) clearance K041679 for COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT, Substantially Equivalent on 2004-12-16. Applicant: Onyx Medical, Inc..

Clearance details

Applicant: Onyx Medical, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2004-06-21
Decision date: 2004-12-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sausalito, CA, 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.