F1 DIODE LASER SYSTEM— 510(k) K004021

Substantially Equivalent

Opus Medical, Inc.

FDA 510(k) clearance K004021 for F1 DIODE LASER SYSTEM, Substantially Equivalent on 2001-03-27. Applicant: Opus Medical, Inc..

Clearance details

Applicant: Opus Medical, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2000-12-27
Decision date: 2001-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albuquerque,, NM, 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.