D-STORM 810NM, D-STORM 980NM— 510(k) K093048

Substantially Equivalent

Light Instruments

FDA 510(k) clearance K093048 for D-STORM 810NM, D-STORM 980NM, Substantially Equivalent on 2010-03-23. Applicant: Light Instruments.

Clearance details

Applicant: Light Instruments
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2009-09-30
Decision date: 2010-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Binyamina, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.