800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES— 510(k) K972575

Substantially Equivalent

Laserscope

FDA 510(k) clearance K972575 for 800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES, Substantially Equivalent on 1998-07-17. Applicant: Laserscope.

Clearance details

Applicant: Laserscope
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1997-07-10
Decision date: 1998-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, 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.