JOULE 810/940/980 MULTI-PLATFORM SYSTEM— 510(k) K122567

Substantially Equivalent

Sciton, Inc

FDA 510(k) clearance K122567 for JOULE 810/940/980 MULTI-PLATFORM SYSTEM, Substantially Equivalent on 2013-06-19. Applicant: Sciton, Inc.

Clearance details

Applicant: Sciton, Inc
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2012-08-23
Decision date: 2013-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, 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.