CURAE'LASE CL1000 IR LASER SYSTEM— 510(k) K053201

Substantially Equivalent

Curae'Lase, Inc.

FDA 510(k) clearance K053201 for CURAE'LASE CL1000 IR LASER SYSTEM, Substantially Equivalent on 2005-12-09. Applicant: Curae'Lase, Inc..

Clearance details

Applicant: Curae'Lase, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2005-11-16
Decision date: 2005-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, 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.