CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES— 510(k) K043319

Substantially Equivalent

Novalis Medical, LLC

FDA 510(k) clearance K043319 for CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES, Substantially Equivalent on 2004-12-17. Applicant: Novalis Medical, LLC.

Clearance details

Applicant: Novalis Medical, LLC
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2004-12-02
Decision date: 2004-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, 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.