GEMINI SURGICAL LASER SYSTEM & ACCESSORIES— 510(k) K034011

Substantially Equivalent

Laserscope

FDA 510(k) clearance K034011 for GEMINI SURGICAL LASER SYSTEM & ACCESSORIES, Substantially Equivalent on 2004-03-30. Applicant: Laserscope.

Clearance details

Applicant: Laserscope
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2003-12-24
Decision date: 2004-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

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.