INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3— 510(k) K060372
Substantially EquivalentIntra Lase Corp.
FDA 510(k) clearance K060372 for INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3, Substantially Equivalent on 2006-08-16. Applicant: Intra Lase Corp..
Clearance details
- Applicant
- Intra Lase Corp.
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, 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.