SCALAR WAVE LASER SYSTEM— 510(k) K091158

Substantially Equivalent

Stellar Lasers

FDA 510(k) clearance K091158 for SCALAR WAVE LASER SYSTEM, Substantially Equivalent on 2009-08-10. Applicant: Stellar Lasers.

Clearance details

Applicant: Stellar Lasers
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2009-04-21
Decision date: 2009-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood Village, 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.