SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921— 510(k) K023624

Substantially Equivalent

Surgical Laser Technologies, Inc.

FDA 510(k) clearance K023624 for SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921, Substantially Equivalent on 2003-01-27. Applicant: Surgical Laser Technologies, Inc..

Clearance details

Applicant: Surgical Laser Technologies, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2002-10-29
Decision date: 2003-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montgomeryville, PA, US

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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.