Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60— 510(k) K192600

Substantially Equivalent

Quanta System Spa

FDA 510(k) clearance K192600 for Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60, Substantially Equivalent on 2020-02-21. Applicant: Quanta System Spa.

Clearance details

Applicant: Quanta System Spa
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2019-09-20
Decision date: 2020-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Samarate, IT

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.