O-pel Laser and families of probe delivery devices— 510(k) K160012

Substantially Equivalent

Precise Light Surgical

FDA 510(k) clearance K160012 for O-pel Laser and families of probe delivery devices, Substantially Equivalent on 2016-06-02. Applicant: Precise Light Surgical.

Clearance details

Applicant: Precise Light Surgical
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2016-01-04
Decision date: 2016-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campbell, 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.