CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND— 510(k) K905453
Substantially EquivalentDouglas James Donaldson Compliance Services
FDA 510(k) clearance K905453 for CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND, Substantially Equivalent on 1991-03-05. Applicant: Douglas James Donaldson Compliance Services.
Clearance details
- Applicant
- Douglas James Donaldson Compliance Services
- Product code
- Code HQF
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakland, CA, US
Adverse events under product code HQF
product code HQF- Injury
- 166
- Other
- 1
- Total
- 167
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.