UltraClear Laser System (N/A)— 510(k) K233803

Substantially Equivalent

Acclaro Corporation

FDA 510(k) clearance K233803 for UltraClear Laser System (N/A), Substantially Equivalent on 2024-05-08. Applicant: Acclaro Corporation.

Clearance details

Applicant: Acclaro Corporation
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2023-11-29
Decision date: 2024-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Smithfield, RI, 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.