The Alma Opus System, Colibri Applicator and Tips— 510(k) K201520

Substantially Equivalent

Alma Lasers, Inc.

FDA 510(k) clearance K201520 for The Alma Opus System, Colibri Applicator and Tips, Substantially Equivalent on 2021-10-27. Applicant: Alma Lasers, Inc..

Clearance details

Applicant: Alma Lasers, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2020-06-08
Decision date: 2021-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo Grove, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.