Catalys Precision Laser System— 510(k) K182083
Substantially EquivalentAmo Manufacturing USA, LLC
FDA 510(k) clearance K182083 for Catalys Precision Laser System, Substantially Equivalent on 2018-11-09. Applicant: Amo Manufacturing USA, LLC.
Clearance details
- Applicant
- Amo Manufacturing USA, LLC
- Product code
- Code OOE
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milpitas, CA, US
Adverse events under product code OOE
product code OOE- Injury
- 1,104
- Malfunction
- 864
- Total
- 1,968
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.