SL-100 ND:YAG LASER FOR GYNECOLOGY USE— 510(k) K871512

Substantially Equivalent

Medical Energy, Inc.

FDA 510(k) clearance K871512 for SL-100 ND:YAG LASER FOR GYNECOLOGY USE, Substantially Equivalent on 1988-07-08. Applicant: Medical Energy, Inc..

Clearance details

Applicant: Medical Energy, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1987-04-20
Decision date: 1988-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pensacola, FL, 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.