SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS— 510(k) K980156

Substantially Equivalent

Surgical Laser Technologies, Inc.

FDA 510(k) clearance K980156 for SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS, Substantially Equivalent on 1998-02-27. Applicant: Surgical Laser Technologies, Inc..

Clearance details

Applicant: Surgical Laser Technologies, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1998-01-16
Decision date: 1998-02-27
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.