Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)— 510(k) K230990
Substantially EquivalentCandela Corporation
FDA 510(k) clearance K230990 for Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta), Substantially Equivalent on 2023-06-01. Applicant: Candela Corporation.
Clearance details
- Applicant
- Candela Corporation
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
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, 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.