CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES— 510(k) K043319
Substantially EquivalentNovalis 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. Device class: 2.
Clearance details
- Applicant
- Novalis Medical, LLC
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tampa, FL, US
Recent devices under product code GEX
view allAdverse 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, through . 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.