ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC.— 510(k) K910825

Substantially Equivalent

Pfizer Laser Systems

FDA 510(k) clearance K910825 for ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC., Substantially Equivalent on 1993-02-26. Applicant: Pfizer Laser Systems.

Clearance details

Applicant: Pfizer Laser Systems
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1991-02-13
Decision date: 1993-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, 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.