CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE— 510(k) K912987
Substantially EquivalentDouglas James Donaldson Compliance Services
FDA 510(k) clearance K912987 for CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE, Substantially Equivalent on 1991-10-28. Applicant: Douglas James Donaldson Compliance Services.
Clearance details
- Applicant
- Douglas James Donaldson Compliance Services
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakland, CA, 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.