SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)— 510(k) K141838
Substantially EquivalentRegulatory Technology Services, LLC
FDA 510(k) clearance K141838 for SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL), Substantially Equivalent on 2014-07-25. Applicant: Regulatory Technology Services, LLC.
Clearance details
- Applicant
- Regulatory Technology Services, LLC
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saint Paul, MN, 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.