Catalys Precision Laser System— 510(k) K200056
Substantially EquivalentAmo Manufacturng USA, LLC
FDA 510(k) clearance K200056 for Catalys Precision Laser System, Substantially Equivalent on 2020-05-18. Applicant: Amo Manufacturng USA, LLC. Device class: 2.
Clearance details
- Applicant
- Amo Manufacturng USA, LLC
- Product code
- Code OOE
- Device class
- Class 2
- Regulation
- 21 CFR 886.4390
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milpitas, CA, US
Recent devices under product code OOE
view allAdverse 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.