RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A— 510(k) K013974

Substantially Equivalent

Trimedyne, Inc.

FDA 510(k) clearance K013974 for RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A, Substantially Equivalent on 2002-09-23. Applicant: Trimedyne, Inc..

Clearance details

Applicant: Trimedyne, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2001-12-03
Decision date: 2002-09-23
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.